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The purpose of this trial is to compare the degree of reflux, operative outcomes and quality of life between Roux en Y and Billroth-I reconstructions after distal subtotal gastrectomy for gastric cancer
Most common procedure for the resection of gastric cancers located in middle or lower stomach is distal subtotal gastrectomy. However, the optimal reconstruction procedure after that has still not to be established. Although B-I reconstruction is most common method due to the safety and simplicity, the duodenal fluid may reflux into the remnant stomach which may contribute to the mucosal injury to remnant stomach and esophagus. Roux en Y reconstruction may reduce the reflux to remnant stomach due to the length of Roux en Y limb, although it is more complicated procedure.
Therefore, we plan to collect 120 patients to compare the degree of reflux between Roux en Y and Billroth-I reconstructions after distal subtotal gastrectomy for gastric cancer. In addition, we compare the surgical outcome and quality of life between two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Billroth-I | Experimental | Patients in this group should be underwent gastroduodenostomy as reconstruction procedure after standard distal subtotal gastrectomy with lymph node dissection. |
|
| Roux en Y | Experimental | Patients in this group should be underwent jejunojejunostomy and gastrojejunostomy as reconstruction procedure after standard distal gastrectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Billroth-I | Procedure | Standard distal gastrectomy with D1 plus beta or D2 lymph node dissection would be performed for distal gastric cancer. After that, gastroduodenostomy should be performed by circular stapler. In addition, stapler sites were re-enforced. |
| Measure | Description | Time Frame |
|---|---|---|
| Reflux of bile content | We estimate the degree of reflux by gastrofiberscopic findings using reflux score suggested by Romaganoli. In addition, histological finding of remnant stomach by endoscopic biopsy is also investigated. Reflux symptom is surveyed by Gastrointestinal Symptom Rating Scale. | 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | We investigate the quality of life with EORTC-C30, EORTC-STO22 questionnaire suggested by European Organization for Research and Treatment of Cancer (EORTC). | 6 months after surgery |
| Morbidity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hoon Hur, M.D. | Contact | +82-31-219-2507 | hhcmc75@naver.com | |
| Sang-Uk Han, M.D. | Contact | +82-31-219-6320 | hansu@ajou.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Sang-Uk Han, M.D., Ph D. | Department of Surgery, Ajou University School of Medicine | Principal Investigator |
| Hoon Hur, M.D. | Department of Surgery, Ajou University School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ajou University Hospital | Recruiting | Suwon | 422-749 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17876675 | Background | Chan DC, Fan YM, Lin CK, Chen CJ, Chen CY, Chao YC. Roux-en-Y reconstruction after distal gastrectomy to reduce enterogastric reflux and Helicobacter pylori infection. J Gastrointest Surg. 2007 Dec;11(12):1732-40. doi: 10.1007/s11605-007-0302-0. Epub 2007 Sep 18. | |
| 16240061 | Background | Ishikawa M, Kitayama J, Kaizaki S, Nakayama H, Ishigami H, Fujii S, Suzuki H, Inoue T, Sako A, Asakage M, Yamashita H, Hatono K, Nagawa H. Prospective randomized trial comparing Billroth I and Roux-en-Y procedures after distal gastrectomy for gastric carcinoma. World J Surg. 2005 Nov;29(11):1415-20; discussion 1421. doi: 10.1007/s00268-005-7830-0. |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D005763 | Gastroenterostomy |
| D000713 | Anastomosis, Roux-en-Y |
| D015390 | Gastric Bypass |
| ID | Term |
|---|---|
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D013505 | Digestive System Surgical Procedures |
| D050110 | Bariatric Surgery |
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|
| Roux en Y | Procedure | Standard distal gastrectomy with D1 plus beta or D2 lymph node dissection would be performed for distal gastric cancer. After that, jejunojejunostomy and gastrojejunostomy should be performed by circular staplers. In addition, stapler sites were re-enforced. |
|
|
We investigate the occurrence of complication during recovery after surgery.
| 2 month after surgery |
| Anastomotic time | We estimate anastomosis time | Day 1 |
| Nutritional state | We estimate Albumin, transferrin, lymphocyte, body weight | 6 month after surgery |
| Mortality | We investigate the occurrence of operation-related death during recovery after surgery. | 2 month after operation |
| Operation time | We estimate total operation time. | Day 1 |
| 34523717 | Derived | Nishizaki D, Ganeko R, Hoshino N, Hida K, Obama K, Furukawa TA, Sakai Y, Watanabe N. Roux-en-Y versus Billroth-I reconstruction after distal gastrectomy for gastric cancer. Cochrane Database Syst Rev. 2021 Sep 15;9(9):CD012998. doi: 10.1002/14651858.CD012998.pub2. |
| 28970956 | Derived | Hur H, Ahn CW, Byun CS, Shin HJ, Kim YB, Son SY, Han SU. A Novel Roux-en-Y Reconstruction Involving the Use of Two Circular Staplers after Distal Subtotal Gastrectomy for Gastric Cancer. J Gastric Cancer. 2017 Sep;17(3):255-266. doi: 10.5230/jgc.2017.17.e32. Epub 2017 Sep 26. |
| D004066 | Digestive System Diseases |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |