Endoscopic Therapy for Bleeding Marginal Ulcers After Gastric Bypass
NCT ID: NCT01040416
Last Updated: 2009-12-29
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
45 participants
Study Classification
OBSERVATIONAL
Study Start Date
2008-12-31
Study Completion Date
2009-12-31
Brief Summary
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The objective of this study is to identify the incidence rate; describe the risk factors, clinical presentation, and endoscopic treatment; assess the morbidity, mortality, and overall performance of the management of patients with actively bleeding marginal ulcers after Roux-en-Y gastric bypass (RYGB) surgery.
Detailed Description
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Marginal ulceration "MU", which presents as an ulcer at the margins of the gastrojejunostomy on the jejunal side, is a common late complication after RYGB. Its incidence after RYGB ranges from as low as 0.6 to as high as 16%. In our hands with the laparoscopic hand-sewn technique for the GJ, the incidence is 1.4%. The presence of specific technical factors - staple-line dehiscence or gastro-gastric fistula, enlarged pouch, foreign material and local ischemia - and environmental factors - tobacco, NSAID´s, alcohol consumption, and H pylori infection among others - have been associated with marginal ulceration however the exact etiopathogenesis has not been completely elucidated.
Similar to peptic ulcer disease (PUD), most marginal ulcers respond to medical therapy, specifically sucralfate and acid-lowering medication. In contrast, complicated marginal ulcers - perforation, bleeding, or chronicity (obstruction, penetration, and intractability)- warrants operative intervention.
Early presentation of hemorrhage after RYGB is mostly related to staple-line failure and may result in either GI or intraabdominal hemorrhage. When indicated, operative interventions consist of either endoscopic therapy, re-operation, or both. In contrast, late presentation of gastrointestinal hemorrhage after RYGB is mostly secondary to a bleeding marginal ulcer however complicated peptic ulcer disease can present in the excluded stomach and duodenum as well.
Most literature available for the management of GI hemorrhage after RYGB is for the early presentation of hemorrhage secondary to staple-line failure. Hence, options for endoscopic hemostatic therapy described in this scenario are I) injection therapy, II) coagulation therapy, III) endoscopic clipping, and IV) a combined modality (for example injection \& coagulation or injection and clipping).
The feasibility, reliability, reproducibility, efficacy, validity and safety of the endoscopic hemostatic therapy for acutely bleeding peptic ulcers has been well documented. Multiple risk-stratification tools for upper-GI hemorrhage have also been developed such as the Blatchford, clinical and complete Rockall scores, and the Forrest classification. Moreover, pre and post endoscopic schemes of PPI´s therapy in patients with bleeding peptic ulcers is effective and cost-saving. However, All of them have not been validated in the obese population status post RYGB complicated with a bleeding marginal ulcer.
Summarizing, there is scant information about the management of late complications after gastric bypass especially after the widespread adoption of the laparoscopic approach and the modern anatomical construct of Roux-en-Y Gastric Bypass surgery. We formally analyze the management efficacy of patients with actively bleeding marginal ulcers after Roux-en-Y gastric bypass (RYGB) surgery.
Similar to peptic ulcer disease (PUD), most marginal ulcers respond to medical therapy, specifically sucralfate and acid-lowering medication. In contrast, complicated marginal ulcers - perforation, bleeding, or chronicity (obstruction, penetration, and intractability)- warrants operative intervention.
Early presentation of hemorrhage after RYGB is mostly related to staple-line failure and may result in either GI or intraabdominal hemorrhage. When indicated, operative interventions consist of either endoscopic therapy, re-operation, or both. In contrast, late presentation of gastrointestinal hemorrhage after RYGB is mostly secondary to a bleeding marginal ulcer however complicated peptic ulcer disease can present in the excluded stomach and duodenum as well.
Most literature available for the management of GI hemorrhage after RYGB is for the early presentation of hemorrhage secondary to staple-line failure. Hence, options for endoscopic hemostatic therapy described in this scenario are I) injection therapy, II) coagulation therapy, III) endoscopic clipping, and IV) a combined modality (for example injection \& coagulation or injection and clipping).
The feasibility, reliability, reproducibility, efficacy, validity and safety of the endoscopic hemostatic therapy for acutely bleeding peptic ulcers has been well documented. Multiple risk-stratification tools for upper-GI hemorrhage have also been developed such as the Blatchford, clinical and complete Rockall scores, and the Forrest classification. Moreover, pre and post endoscopic schemes of PPI´s therapy in patients with bleeding peptic ulcers is effective and cost-saving. However, All of them have not been validated in the obese population status post RYGB complicated with a bleeding marginal ulcer.
Summarizing, there is scant information about the management of late complications after gastric bypass especially after the widespread adoption of the laparoscopic approach and the modern anatomical construct of Roux-en-Y Gastric Bypass surgery. We formally analyze the management efficacy of patients with actively bleeding marginal ulcers after Roux-en-Y gastric bypass (RYGB) surgery.
Conditions
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Bleeding Marginal Ulcer
Keywords
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complicated marginal ulcer
complex marginal ulcer
complication after gastric bypass
gastrointestinal hemorrhage
Study Design
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Observational Model Type
COHORT
Study Time Perspective
RETROSPECTIVE
Study Groups
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Bleeding marginal ulcer after RYGB
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* patients status post laparoscopic RYGB surgery with active gastrointestinal hemorrhage secondary to marginal ulcer
Exclusion Criteria
* bleeding marginal ulcers after other bariatric procedures
* staple-line bleeding after RYGB
* iron-deficiency anemia (chronic) secondary to non-actively bleeding marginal ulcer after RYGB
* other sources of GI bleeding different from marginal ulcer such as from staple-lines, complicated PUD, and other surgical and medical causes of GI hemorrhage
* missing records and/or unreachable patients with scant information for analysis
* staple-line bleeding after RYGB
* iron-deficiency anemia (chronic) secondary to non-actively bleeding marginal ulcer after RYGB
* other sources of GI bleeding different from marginal ulcer such as from staple-lines, complicated PUD, and other surgical and medical causes of GI hemorrhage
* missing records and/or unreachable patients with scant information for analysis
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of California, San Francisco
OTHER
Sponsor Role
lead
Responsible Party
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UCSF Fresno / ALSA Medical Group, Inc. Minimally Invasive Surgery Program
Principal Investigators
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Francisco M Tercero, MD
Role: STUDY_DIRECTOR
Research Associate, University of California San Francisco
Kelvin D Higa, MD
Role: PRINCIPAL_INVESTIGATOR
Professor of Surgery, University of California San Francisco
Locations
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UCSF Fresno Center for Medical Education and Research
Fresno, California, United States
Site Status
Countries
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United States
References
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Sacks BC, Mattar SG, Qureshi FG, Eid GM, Collins JL, Barinas-Mitchell EJ, Schauer PR, Ramanathan RC. Incidence of marginal ulcers and the use of absorbable anastomotic sutures in laparoscopic Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2006 Jan-Feb;2(1):11-6. doi: 10.1016/j.soard.2005.10.013.
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BACKGROUND
Related Links
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http://www.fresno.ucsf.edu/surgery
"Click here for more information about the department sponsor´s web site"
Other Identifiers
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U1111-1112-9849
Identifier Type: OTHER
Identifier Source: secondary_id
CMC IRB No. 2008081
Identifier Type: -
Identifier Source: org_study_id