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We grafted the concept of metabolic surgery (long limb Roux-en Y reconstruction) into gastric cancer surgery. This study aimed to investigate the safety and efficacy of long limb Roux-en Y reconstruction after gastrectomy in non-obese type II diabetes with gastric cancer.
Type II diabetes in the world is increasing rapidly, and it is known that patients with type II diabetes with morbid obesity that underwent bariatric surgery have resolution of impaired glucose metabolism.
In Asia, most type II diabetes are not morbidly obese and still, it is controversy whether metabolic surgery is effective or not in non-morbid obese patients. As life expectancy is increased, the number of patients with gastric cancer and T2DM is increased as well.
Recently, we studied the outcome of T2DM after gastrectomy and conventional reconstruction in non-obese gastric cancer patients.(Kim JW et al, World J Gastroenterol 2012;18:49) The study was a large-series retrospective study including about 400 patients and the result regarding DM improvement was not satisfactory. Based on our previous results, it is needed to find more effective way to resolve the type II diabetes in gastrectomized patients with gastric cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long limb Roux-en Y reconstruction | Experimental | Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Long limb Roux-en Y reconstruction | Procedure | After radical gastrectomy, the gastrointestinal tract was reconstructed by Roux-en-Y gastrojejunostomy or esophagojejunostomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity | For the evaluation of safety, morbidity were analyzed. For the evaluation of short-term safety, complications higher than the Clavien-Dindo grade II (Dindo et. Ann Surg 240:205 2004) were collected. *Clavien-dindo classification of surgical complications Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. Grade III: Requiring surgical, endoscopic or radiological intervention Grade IV:Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management Grade V:Death of a patient Suffix'd' : If the patient suffers from a complication at the time of discharge ,the suffix "d" (for 'disability') is added to the respective grade of complication. This label indicates the need for a follow-up to fully evaluate the complication. For the evaluation of long-term safety, the patients were evaluated every month after discharge. | Until end of study (on average 14.8 months) |
| HbA1c | For the evaluation of efficacy for the operation, HbA1c(%) was measured serially (preop. 6months after op. until end of study(on average 14.8 months)). HbA1c is formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose and measured by high-performance liquid chromatography (HPLC) The HbA1c was calculated as a ratio to total hemoglobin. | Before operation , 6 months after operation, Until end of study (on average 14.8 months) |
| Hemoglobin | For the evaluation of long-term safety, hemoglobin was measured to determine the degree of anemia and malnutrition. | Before operation , 6 months after operation, Until end of study (on average 14.8 months) |
| Albumin | For the evaluation of long-term safety, albumin was measured to determine malnutrition. | Before operation , 6 months after operation, Until end of study (on average 14.8 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Matsuda Index | Matsuda Index(Insulin Sensitivity Index) was measured. The Matsuda index was obtained using the following formula: Matsuda index = 10000/square root of [(fasting glucose × fasting insulin) × (mean glucose × mean insulin during OGTT)] | Before operation , 6 months after operation, Until end of study (on average 14.8 months) |
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Inclusion Criteria:
Pathologically confirmed gastric cancer with potentially curable state
Non-obese (Body mass index: less than 30 kg/m2)
Have a history of Type 2 DM over 6 months (diagnosed by ADA criteria)
C-peptide level: above 1ng/ml
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seung Ho Choi, M.D., Ph.D. | Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GangNam Severance Hospital | Seoul | 146-92 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19272486 | Background | Buchwald H, Estok R, Fahrbach K, Banel D, Jensen MD, Pories WJ, Bantle JP, Sledge I. Weight and type 2 diabetes after bariatric surgery: systematic review and meta-analysis. Am J Med. 2009 Mar;122(3):248-256.e5. doi: 10.1016/j.amjmed.2008.09.041. | |
| 7677463 | Background | Pories WJ, Swanson MS, MacDonald KG, Long SB, Morris PG, Brown BM, Barakat HA, deRamon RA, Israel G, Dolezal JM, et al. Who would have thought it? An operation proves to be the most effective therapy for adult-onset diabetes mellitus. Ann Surg. 1995 Sep;222(3):339-50; discussion 350-2. doi: 10.1097/00000658-199509000-00011. |
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If Patients were eligible for the study, each patient was informed of the investigational nature of the trial and received detailed information regarding the study protocol. All patients provided written informed consent before their enrollment. The enrollment continued from February 2010 through May 2011 in Gangnam Severance Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Long Limb Roux-en Y Reconstruction | Total or Subtotal gastrectomized gastric cancer patient with long limb Roux en Y reconstruction |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Long Limb Roux-en Y Reconstruction | Total or Subtotal gastrectomized gastric cancer patient with long limb Roux en Y reconstruction |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Matsuda Index | Matsuda Index(Insulin Sensitivity Index) was measured. The Matsuda index was obtained using the following formula: Matsuda index = 10000/square root of [(fasting glucose × fasting insulin) × (mean glucose × mean insulin during OGTT)] | Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation. | Posted | Mean | Standard Deviation | units on a scale | Before operation , 6 months after operation, Until end of study (on average 14.8 months) |
|
Until end of study (on average 14.8 months)
Daily check up during hospitalization after operation. check up every month after discharge.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Long-limb Roux-en Y Reconstruction | Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| myocardiac infart | Cardiac disorders | SNOMED CT | Systematic Assessment | One had myocardial infarction treated with percutaneous transluminal coronary angioplasty with stent insertion. The patient recovered well without sequela. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anastomosis, non-functional (morphologic abnormality) | Surgical and medical procedures | SNOMED CT | Systematic Assessment | Managed with temporary stent insertion |
One mortality due to early recurrence leading to reduced number of subject analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Seung Ho Choi, M.D., Ph.D. | Gangnam severance hospital | 82-2-2019-3374 | choish@yuhs.ac |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
|
| Operation Related Mortality | Operation related mortality was measured for the evaluation of safety for the operation. Operation related mortality was defined as any complication resulting in the death of the patient within 1 month or during hospitalization after operation. | Until end of study (on average 14.8 months) |
| QUICKI |
The quantitative insulin sensitivity check index (QUICKI) was measured. The QUICKI was obtained using the following formula: 1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL)) |
| Before operation , 6 months after operation , Until end of study (on average 14.8 months) |
| HOMA-IR | HOMA-IR(Homeostasis model assessment-estimated insulin resistance) was measured. HOMA-IR was obtained using the following formula: Glucose(mg/dl) x Insulin/405 | Before operation , 6 months after operation, Until end of study (on average 14.8 months) |
| HOMA-B | HOMA-B(Homoeostasis model assessment-derived beta-cell function) was measured. HOMA-B was obtained using the following formula: 225 × 18/fasting insulin(mU/L) × fasting glucose(mg/dL) | Before operation , 6 months after operation, Until end of study (on average 14.8 months) |
| Body Mass Index | BMI(Body Mass index , kg/㎡) was measured. BMI was obtained using the following formula: Weight (kg) / (Height (m) x Height (m)) | Before operation, 6 Months After Operation, Until End of Study(on Average 14.8 Months) |
| Matsuda Index : Good Response Group | At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation. We called this group as "good response group". We analyzed the change of insulin sensitivity after operation in good response group. The Matsuda index(Insulin Sensitivity Index) was obtained using the following formula: Matsuda index = 10000/square root of [(fasting glucose × fasting insulin) × (mean glucose × mean insulin during OGTT)] | Before operation , 6 months after operation, Until end of study (on average 14.8 months) |
| QUICKI : Good Response Group | At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of insulin sensitivity after operation in good response group. The quantitative insulin sensitivity check index (QUICKI) was measured. The QUICKI is obtained using the following formula: 1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL)) | Before operation, 6 months after operation, Until end of study (on average 14.8 months) |
| HOMA-IR : Good Response Group | At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of insulin resistance after operation in good response group. HOMA-IR(Homeostasis model assessment-estimated insulin resistance) was measured. HOMA-IR was obtained using the following formula: Glucose(mg/dl) x Insulin/405 | Before operation, 6 months after operation, Until end of study (on average 14.8 months) |
| HOMA-B : Good Response Group | At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of beta-cell function after operation in good response group. HOMA-B(Homoeostasis model assessment-derived beta-cell function) was measured. HOMA-B was obtained using the following formula: 225 × 18/fasting insulin(mU/L) × fasting glucose(mg/dL) | Before operation, 6 months after operation, Until end of study (on average 14.8 months) |
| Body Mass Index : Good Response Group | At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of weight change after operation in good response group. BMI(Body Mass index , kg/㎡) was measured. BMI was obtained using the following formula: Weight (kg) / (Height (m) x Height (m)) | Before operation, 6 months after operation, Until end of study (on average 14.8 months) |
| HbA1c : Good Response Group | At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of HbA1c after operation in good response group. HbA1c is formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose and measured by high-performance liquid chromatography (HPLC) The HbA1c was calculated as a ratio to total hemoglobin. | Before operation, 6 months after operation, Until end of study (on average 14.8 months) |
| Hemoglobin : Good Response Group | At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". For the evaluation of long-term safety, hemoglobin was measured to determine the degree of anemia and malnutrition in good response group. | Before operation, 6 months after operation, Until end of study (on average 14.8 months) |
| Albumin : Good Response Group | At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of albumin level after operation in good response group for the evaluation of long-term safety. | Before operation, 6 months after operation, Until end of study (on average 14.8 months) |
| 17098087 | Background | Yoon KH, Lee JH, Kim JW, Cho JH, Choi YH, Ko SH, Zimmet P, Son HY. Epidemic obesity and type 2 diabetes in Asia. Lancet. 2006 Nov 11;368(9548):1681-8. doi: 10.1016/S0140-6736(06)69703-1. |
| 13238177 | Background | FRIEDMAN MN, SANCETTA AJ, MAGOVERN GJ. The amelioration of diabetes mellitus following subtotal gastrectomy. Surg Gynecol Obstet. 1955 Feb;100(2):201-4. No abstract available. |
| 13683582 | Background | ANGERVALL L, DOTEVALL G, TILLANDER H. Amelioration of diabetes mellitus following gastric resection. Acta Med Scand. 1961 Jun;169:743-8. doi: 10.1111/j.0954-6820.1961.tb07885.x. No abstract available. |
| 20863527 | Background | Yang J, Li C, Liu H, Gu H, Chen P, Liu B. Effects of subtotal gastrectomy and Roux-en-Y gastrojejunostomy on the clinical outcome of type 2 diabetes mellitus. J Surg Res. 2010 Nov;164(1):e67-71. doi: 10.1016/j.jss.2010.07.004. Epub 2010 Jul 30. |
| 22228970 | Background | Kim JW, Cheong JH, Hyung WJ, Choi SH, Noh SH. Outcome after gastrectomy in gastric cancer patients with type 2 diabetes. World J Gastroenterol. 2012 Jan 7;18(1):49-54. doi: 10.3748/wjg.v18.i1.49. |
| 20587713 | Background | DeFronzo RA, Matsuda M. Reduced time points to calculate the composite index. Diabetes Care. 2010 Jul;33(7):e93. doi: 10.2337/dc10-0646. No abstract available. |
| 10332688 | Background | Emoto M, Nishizawa Y, Maekawa K, Hiura Y, Kanda H, Kawagishi T, Shoji T, Okuno Y, Morii H. Homeostasis model assessment as a clinical index of insulin resistance in type 2 diabetic patients treated with sulfonylureas. Diabetes Care. 1999 May;22(5):818-22. doi: 10.2337/diacare.22.5.818. |
| 10902785 | Background | Katz A, Nambi SS, Mather K, Baron AD, Follmann DA, Sullivan G, Quon MJ. Quantitative insulin sensitivity check index: a simple, accurate method for assessing insulin sensitivity in humans. J Clin Endocrinol Metab. 2000 Jul;85(7):2402-10. doi: 10.1210/jcem.85.7.6661. |
| 21461399 | Background | Frenken M, Cho EY, Karcz WK, Grueneberger J, Kuesters S. Improvement of type 2 diabetes mellitus in obese and non-obese patients after the duodenal switch operation. J Obes. 2011;2011:860169. doi: 10.1155/2011/860169. Epub 2011 Mar 3. |
| 21336559 | Background | Navarrete SA, Leyba JL, Llopis SN. Laparoscopic sleeve gastrectomy with duodenojejunal bypass for the treatment of type 2 diabetes in non-obese patients: technique and preliminary results. Obes Surg. 2011 May;21(5):663-7. doi: 10.1007/s11695-011-0371-8. |
| 16925363 | Background | Cohen R, Pinheiro JS, Correa JL, Schiavon CA. Laparoscopic Roux-en-Y gastric bypass for BMI < 35 kg/m(2): a tailored approach. Surg Obes Relat Dis. 2006 May-Jun;2(3):401-4, discussion 404. doi: 10.1016/j.soard.2006.02.011. |
| 18830750 | Background | DePaula AL, Macedo AL, Mota BR, Schraibman V. Laparoscopic ileal interposition associated to a diverted sleeve gastrectomy is an effective operation for the treatment of type 2 diabetes mellitus patients with BMI 21-29. Surg Endosc. 2009 Jun;23(6):1313-20. doi: 10.1007/s00464-008-0156-x. Epub 2008 Oct 2. |
| 17386401 | Background | Cohen RV, Schiavon CA, Pinheiro JS, Correa JL, Rubino F. Duodenal-jejunal bypass for the treatment of type 2 diabetes in patients with body mass index of 22-34 kg/m2: a report of 2 cases. Surg Obes Relat Dis. 2007 Mar-Apr;3(2):195-7. doi: 10.1016/j.soard.2007.01.009. No abstract available. |
| 21479976 | Background | Orci L, Chilcott M, Huber O. Short versus long Roux-limb length in Roux-en-Y gastric bypass surgery for the treatment of morbid and super obesity: a systematic review of the literature. Obes Surg. 2011 Jun;21(6):797-804. doi: 10.1007/s11695-011-0409-y. |
| 17060767 | Background | Rubino F, Forgione A, Cummings DE, Vix M, Gnuli D, Mingrone G, Castagneto M, Marescaux J. The mechanism of diabetes control after gastrointestinal bypass surgery reveals a role of the proximal small intestine in the pathophysiology of type 2 diabetes. Ann Surg. 2006 Nov;244(5):741-9. doi: 10.1097/01.sla.0000224726.61448.1b. |
| 15273542 | Background | Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Morbidity | For the evaluation of safety, morbidity were analyzed. For the evaluation of short-term safety, complications higher than the Clavien-Dindo grade II (Dindo et. Ann Surg 240:205 2004) were collected. *Clavien-dindo classification of surgical complications Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. Grade III: Requiring surgical, endoscopic or radiological intervention Grade IV:Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management Grade V:Death of a patient Suffix'd' : If the patient suffers from a complication at the time of discharge ,the suffix "d" (for 'disability') is added to the respective grade of complication. This label indicates the need for a follow-up to fully evaluate the complication. For the evaluation of long-term safety, the patients were evaluated every month after discharge. | All of enrolled patient were included. (N=15) | Posted | Number | participants | Until end of study (on average 14.8 months) |
|
|
|
| Secondary | QUICKI | The quantitative insulin sensitivity check index (QUICKI) was measured. The QUICKI was obtained using the following formula: 1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL)) | Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation. | Posted | Mean | Standard Deviation | units on a scale | Before operation , 6 months after operation , Until end of study (on average 14.8 months) |
|
|
|
| Secondary | HOMA-IR | HOMA-IR(Homeostasis model assessment-estimated insulin resistance) was measured. HOMA-IR was obtained using the following formula: Glucose(mg/dl) x Insulin/405 | Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation. | Posted | Mean | Standard Deviation | units on a scale | Before operation , 6 months after operation, Until end of study (on average 14.8 months) |
|
|
|
| Secondary | HOMA-B | HOMA-B(Homoeostasis model assessment-derived beta-cell function) was measured. HOMA-B was obtained using the following formula: 225 × 18/fasting insulin(mU/L) × fasting glucose(mg/dL) | Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation. | Posted | Mean | Standard Deviation | percentage of beta cell function | Before operation , 6 months after operation, Until end of study (on average 14.8 months) |
|
|
|
| Secondary | Body Mass Index | BMI(Body Mass index , kg/㎡) was measured. BMI was obtained using the following formula: Weight (kg) / (Height (m) x Height (m)) | Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation. | Posted | Mean | Standard Deviation | kg/㎡ | Before operation, 6 Months After Operation, Until End of Study(on Average 14.8 Months) |
|
|
|
| Primary | HbA1c | For the evaluation of efficacy for the operation, HbA1c(%) was measured serially (preop. 6months after op. until end of study(on average 14.8 months)). HbA1c is formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose and measured by high-performance liquid chromatography (HPLC) The HbA1c was calculated as a ratio to total hemoglobin. | Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation. | Posted | Mean | Standard Deviation | percentage of glycated hemoglobin | Before operation , 6 months after operation, Until end of study (on average 14.8 months) |
|
|
|
| Primary | Hemoglobin | For the evaluation of long-term safety, hemoglobin was measured to determine the degree of anemia and malnutrition. | Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the long-term safety evaluation. | Posted | Mean | Standard Deviation | g/dl | Before operation , 6 months after operation, Until end of study (on average 14.8 months) |
|
|
|
| Primary | Albumin | For the evaluation of long-term safety, albumin was measured to determine malnutrition. | Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the long-term safety evaluation. | Posted | Mean | Standard Deviation | g/dl | Before operation , 6 months after operation, Until end of study (on average 14.8 months) |
|
|
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| Primary | Operation Related Mortality | Operation related mortality was measured for the evaluation of safety for the operation. Operation related mortality was defined as any complication resulting in the death of the patient within 1 month or during hospitalization after operation. | All of enrolled patient were included.(N=15) | Posted | Number | participants | Until end of study (on average 14.8 months) |
|
|
|
| Secondary | Matsuda Index : Good Response Group | At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation. We called this group as "good response group". We analyzed the change of insulin sensitivity after operation in good response group. The Matsuda index(Insulin Sensitivity Index) was obtained using the following formula: Matsuda index = 10000/square root of [(fasting glucose × fasting insulin) × (mean glucose × mean insulin during OGTT)] | At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as "good responder group". We analyzed the change of insulin sensitivity after operation in good responder group. | Posted | Mean | Standard Deviation | units on a scale | Before operation , 6 months after operation, Until end of study (on average 14.8 months) |
|
|
|
| Secondary | QUICKI : Good Response Group | At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of insulin sensitivity after operation in good response group. The quantitative insulin sensitivity check index (QUICKI) was measured. The QUICKI is obtained using the following formula: 1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL)) | At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as "good responder group". We analyzed the change of QUICKI after operation in good responder group. | Posted | Mean | Standard Deviation | units on a scale | Before operation, 6 months after operation, Until end of study (on average 14.8 months) |
|
|
|
| Secondary | HOMA-IR : Good Response Group | At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of insulin resistance after operation in good response group. HOMA-IR(Homeostasis model assessment-estimated insulin resistance) was measured. HOMA-IR was obtained using the following formula: Glucose(mg/dl) x Insulin/405 | At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as "good responder group". We analyzed the change of HOMA-IR after operation in good responder group. | Posted | Mean | Standard Deviation | units on a scale | Before operation, 6 months after operation, Until end of study (on average 14.8 months) |
|
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| Secondary | HOMA-B : Good Response Group | At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of beta-cell function after operation in good response group. HOMA-B(Homoeostasis model assessment-derived beta-cell function) was measured. HOMA-B was obtained using the following formula: 225 × 18/fasting insulin(mU/L) × fasting glucose(mg/dL) | At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as "good responder group". We analyzed the change of beta cell function after operation in good responder group. | Posted | Mean | Standard Deviation | percentage of beta cell function | Before operation, 6 months after operation, Until end of study (on average 14.8 months) |
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| Secondary | Body Mass Index : Good Response Group | At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of weight change after operation in good response group. BMI(Body Mass index , kg/㎡) was measured. BMI was obtained using the following formula: Weight (kg) / (Height (m) x Height (m)) | At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as "good responder group". We analyzed the change of weight after operation in good responder group. | Posted | Mean | Standard Deviation | kg/㎡ | Before operation, 6 months after operation, Until end of study (on average 14.8 months) |
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| Secondary | HbA1c : Good Response Group | At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of HbA1c after operation in good response group. HbA1c is formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose and measured by high-performance liquid chromatography (HPLC) The HbA1c was calculated as a ratio to total hemoglobin. | At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as "good responder group". We analyzed the change of HbA1c after operation in good responder group. | Posted | Mean | Standard Deviation | percentage of glycated hemoglobin | Before operation, 6 months after operation, Until end of study (on average 14.8 months) |
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| Secondary | Hemoglobin : Good Response Group | At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". For the evaluation of long-term safety, hemoglobin was measured to determine the degree of anemia and malnutrition in good response group. | At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We analyzed the change of hemoglobin after operation in good responder group for the evaluation of long-term safety. | Posted | Mean | Standard Deviation | g/dl | Before operation, 6 months after operation, Until end of study (on average 14.8 months) |
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| Secondary | Albumin : Good Response Group | At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of albumin level after operation in good response group for the evaluation of long-term safety. | At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We analyzed the change of albumin level after operation for the evaluation of long-term safety in good responder group. | Posted | Mean | Standard Deviation | g/dl | Before operation, 6 months after operation, Until end of study (on average 14.8 months) |
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| 2 |
| 15 |
| 3 |
| 15 |
|
| dead | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | SNOMED CT | Systematic Assessment | One patient had poorly differentiated neuroendocrine carcinoma, which was most aggressive gastric cancer and died due to recurrence four months after surgery. (preoperative diagnosis: poorly differentiated adenocarcinoma) |
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| Stricture of anastomosis of intestine | Surgical and medical procedures | SNOMED CT | Systematic Assessment | Recovered with conservative management |
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| Open wound of abdominal wall with complication | Skin and subcutaneous tissue disorders | SNOMED CT | Systematic Assessment | Managed with wound closure by retension suture technique under general anesthesia. |
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Not provided
Not provided
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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