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Small-balloon enteroscopy is a novel endoscopy system for examination of the deep small intestine.Initial reports indicated that CO2 was effective during the colonoscopy ,ERCP(endoscopic retrograde cholangiopancreatography) and DBE(double-balloon enteroscopy) examination, but it is still uncertain to the SBE(single-balloon enteroscopy) procedure.
Currently, air is more frequently used to insufflate gas into the lumen to ensure the visualization of the mucosa. However, there're some limitations, for instance, significant amounts of air are usually retained in the small bowel, which will lead to the distention and the pain of the gastrointestinal tract during and after the procedure.
Carbon dioxide(CO2), comparing to the air, is rapidly absorbed from the intestine, which allows the bowel to decompress more quickly and potentially decreases intraprocedural and postprocedural pain, sedation medication requirements, procedure time, and recovery time. It is also to the benefit of deeper intubation depth so that higher total enteroscopy rate and diagnostic rate will be achieved.
Initial reports indicated that CO2 was effective during the colonoscopy ,ERCP and DBE examination, but it is still uncertain to the SBE procedure
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Air insufflation regulator | Active Comparator | Room air will be used for insufflation as the Active Comparator arm |
|
| CO2 insufflation regulator | Experimental | Device: CO2 insufflation regulator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CO2 insufflation regulator | Device | The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE. |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation Depth | Within 5 minutes after the examination |
| Measure | Description | Time Frame |
|---|---|---|
| Total Enteroscopy Rate | Within 1 week after all the examinations are finished | |
| Diagnostic Rate | Within 1 week after all the examinations are finished | |
| Patient's Acceptability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhizheng Ge, Ph.D. MD. | Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine Shanghai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200127 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18058613 | Background | Tsujikawa T, Saitoh Y, Andoh A, Imaeda H, Hata K, Minematsu H, Senoh K, Hayafuji K, Ogawa A, Nakahara T, Sasaki M, Fujiyama Y. Novel single-balloon enteroscopy for diagnosis and treatment of the small intestine: preliminary experiences. Endoscopy. 2008 Jan;40(1):11-5. doi: 10.1055/s-2007-966976. Epub 2007 Dec 4. | |
| 18599052 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | CO2(Carbon Dioxide) Insufflation Regulator | Device: CO2 insufflation regulator CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE(single-balloon enteroscopy). |
| FG001 | Air Insufflation Regulator | Room air will be used for insufflation as the Active Comparator arm Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CO2 Insufflation Regulator | Device: CO2 insufflation regulator CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intubation Depth | Posted | Mean | Standard Deviation | cm | Within 5 minutes after the examination |
|
Adverse event was defined as any event that changed the health status of a patient, occurring within 30 days after enteroscopy examination.
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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 | CO2 Insufflation Regulator | Device: CO2 insufflation regulator CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acute haemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zhizheng Ge, MD. Ph.D. Director of the Clinical Trials | Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine | 86-21-68383015 | zhizhengge@yahoo.com.cn |
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| ID | Term |
|---|---|
| D011029 | Pneumoradiography |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| Air insufflation | Device | The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE. |
|
Acceptability was recorded on a questionnaire given to patients after the examination. Patients assessed the degree of abdominal pain/distention along a 10-cm line of the VAS(visual analogue scale), with the 0-cm point labeled "no pain/distention" on left end and the 10-cm point labeled "very severe pain/distention that cannot be tolerated" on the right end. Patients were asked to score the severity of pain/distention experienced at 1, 2, 3 and 6 hours after the completion of the entire examination. |
| 6 hours after the examination |
| Procedure Time | Within 5 minutes after the examination |
| Abdominal Circumference | To measure abdominal circumference, a tape was placed horizontally around the abdomen at the level of the middle location between the level of anterior superior iliac spine and the lower edge of costal arch, and the measurement was made at the end of a normal expiration before and after the procedure. | 10 minutes before/after the examination |
| Complication Rate | Within 1 week after all the examinations are finished |
| Kawamura T, Yasuda K, Tanaka K, Uno K, Ueda M, Sanada K, Nakajima M. Clinical evaluation of a newly developed single-balloon enteroscope. Gastrointest Endosc. 2008 Dec;68(6):1112-6. doi: 10.1016/j.gie.2008.03.1063. Epub 2008 Jul 2. |
| 20541189 | Background | Frantz DJ, Dellon ES, Grimm IS, Morgan DR. Single-balloon enteroscopy: results from an initial experience at a U.S. tertiary-care center. Gastrointest Endosc. 2010 Aug;72(2):422-6. doi: 10.1016/j.gie.2010.03.1117. Epub 2010 Jun 11. |
| 18072057 | Background | Domagk D, Bretthauer M, Lenz P, Aabakken L, Ullerich H, Maaser C, Domschke W, Kucharzik T. Carbon dioxide insufflation improves intubation depth in double-balloon enteroscopy: a randomized, controlled, double-blind trial. Endoscopy. 2007 Dec;39(12):1064-7. doi: 10.1055/s-2007-966990. |
| 19152906 | Background | Dellon ES, Hawk JS, Grimm IS, Shaheen NJ. The use of carbon dioxide for insufflation during GI endoscopy: a systematic review. Gastrointest Endosc. 2009 Apr;69(4):843-9. doi: 10.1016/j.gie.2008.05.067. Epub 2009 Jan 18. |
| 21237455 | Background | Hirai F, Beppu T, Nishimura T, Takatsu N, Ashizuka S, Seki T, Hisabe T, Nagahama T, Yao K, Matsui T, Beppu T, Nakashima R, Inada N, Tajiri E, Mitsuru H, Shigematsu H. Carbon dioxide insufflation compared with air insufflation in double-balloon enteroscopy: a prospective, randomized, double-blind trial. Gastrointest Endosc. 2011 Apr;73(4):743-9. doi: 10.1016/j.gie.2010.10.003. Epub 2011 Jan 14. |
| 20051942 | Background | May A, Farber M, Aschmoneit I, Pohl J, Manner H, Lotterer E, Moschler O, Kunz J, Gossner L, Monkemuller K, Ell C. Prospective multicenter trial comparing push-and-pull enteroscopy with the single- and double-balloon techniques in patients with small-bowel disorders. Am J Gastroenterol. 2010 Mar;105(3):575-81. doi: 10.1038/ajg.2009.712. Epub 2010 Jan 5. |
| 10839527 | Background | Iddan G, Meron G, Glukhovsky A, Swain P. Wireless capsule endoscopy. Nature. 2000 May 25;405(6785):417. doi: 10.1038/35013140. No abstract available. |
| 11174299 | Background | Yamamoto H, Sekine Y, Sato Y, Higashizawa T, Miyata T, Iino S, Ido K, Sugano K. Total enteroscopy with a nonsurgical steerable double-balloon method. Gastrointest Endosc. 2001 Feb;53(2):216-20. doi: 10.1067/mge.2001.112181. |
| 19686408 | Background | Ramchandani M, Reddy DN, Gupta R, Lakhtakia S, Tandan M, Rao GV, Darisetty S. Diagnostic yield and therapeutic impact of single-balloon enteroscopy: series of 106 cases. J Gastroenterol Hepatol. 2009 Oct;24(10):1631-8. doi: 10.1111/j.1440-1746.2009.05936.x. Epub 2009 Aug 3. |
| 20178072 | Background | Aktas H, de Ridder L, Haringsma J, Kuipers EJ, Mensink PB. Complications of single-balloon enteroscopy: a prospective evaluation of 166 procedures. Endoscopy. 2010 May;42(5):365-8. doi: 10.1055/s-0029-1243931. Epub 2010 Feb 22. |
| 20409544 | Background | Upchurch BR, Sanaka MR, Lopez AR, Vargo JJ. The clinical utility of single-balloon enteroscopy: a single-center experience of 172 procedures. Gastrointest Endosc. 2010 Jun;71(7):1218-23. doi: 10.1016/j.gie.2010.01.012. Epub 2010 Apr 20. |
| 24626435 | Derived | Li X, Zhao YJ, Dai J, Li XB, Xue HB, Zhang Y, Xiong GS, Ohtsuka K, Gao YJ, Liu Q, Song Y, Fang JY, Ge ZZ. Carbon dioxide insufflation improves the intubation depth and total enteroscopy rate in single-balloon enteroscopy: a randomised, controlled, double-blind trial. Gut. 2014 Oct;63(10):1560-5. doi: 10.1136/gutjnl-2013-306069. Epub 2014 Mar 13. |
| BG001 | Air Insufflation Regulator | Room air will be used for insufflation as the Active Comparator arm Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Course of disease (month) | Mean | Standard Deviation | months |
|
| indications | Number | participants |
|
|
|
| Secondary | Total Enteroscopy Rate | Posted | Number | participants | Within 1 week after all the examinations are finished |
|
|
|
| Secondary | Diagnostic Rate | Posted | Number | Percentage of Participants | Within 1 week after all the examinations are finished |
|
|
|
| Secondary | Patient's Acceptability | Acceptability was recorded on a questionnaire given to patients after the examination. Patients assessed the degree of abdominal pain/distention along a 10-cm line of the VAS(visual analogue scale), with the 0-cm point labeled "no pain/distention" on left end and the 10-cm point labeled "very severe pain/distention that cannot be tolerated" on the right end. Patients were asked to score the severity of pain/distention experienced at 1, 2, 3 and 6 hours after the completion of the entire examination. | Posted | Number | participants | 6 hours after the examination |
|
|
|
| Secondary | Procedure Time | Posted | Mean | Standard Deviation | minutes | Within 5 minutes after the examination |
|
|
|
| Secondary | Abdominal Circumference | To measure abdominal circumference, a tape was placed horizontally around the abdomen at the level of the middle location between the level of anterior superior iliac spine and the lower edge of costal arch, and the measurement was made at the end of a normal expiration before and after the procedure. | Posted | Mean | Standard Deviation | centimeter | 10 minutes before/after the examination |
|
|
|
| Secondary | Complication Rate | Posted | Number | participants | Within 1 week after all the examinations are finished |
|
|
|
| 1 |
| 106 |
| 0 |
| 106 |
| EG001 | Air Insufflation Regulator | Room air will be used for insufflation as the Active Comparator arm Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE. | 1 | 108 | 0 | 108 |
| acute pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
|
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| Total enteroscopy examinations |
|