Endoscopic Therapy for Bleeding Marginal Ulcers After Gastric Bypass (BleedingMU)
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Purpose
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.
| Condition |
|---|
|
Bleeding Marginal Ulcer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Endoscopic Therapy for Actively Bleeding Marginal Ulcers: Our Experience After 7,020 Roux-en-Y Gastric Bypass Surgeries |
- Morbidity and mortality, overall [ Time Frame: throughout follow-up ] [ Designated as safety issue: Yes ]
- re-bleeding, gastrointestinal hemorrhage secondary to marginal ulceration [ Time Frame: throughout follow-up ] [ Designated as safety issue: Yes ]
- marginal ulcer recurrence [ Time Frame: at last follow-up ] [ Designated as safety issue: Yes ]
- Symptom resolution, marginal ulcer [ Time Frame: at last follow-up ] [ Designated as safety issue: No ]
- consumption of blood products [ Time Frame: during bleeding-related hospitalization ] [ Designated as safety issue: No ]
- weight loss expressed as Body Mass Index and Percentage excess weight loss [ Time Frame: at the lowest point and yearly intervals ] [ Designated as safety issue: No ]
| Enrollment: | 45 |
| Study Start Date: | December 2008 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Bleeding marginal ulcer after RYGB |
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with actively bleeding marginal ulcers after Roux-en-Y gastric bypass (RYGB) surgery.
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
Contacts and Locations| United States, California | |
| UCSF Fresno Center for Medical Education and Research | |
| Fresno, California, United States, 93701 | |
| Study Director: | Francisco M Tercero, MD | Research Associate, University of California San Francisco |
| Principal Investigator: | Kelvin D Higa, MD | Professor of Surgery, University of California San Francisco |
More Information
Additional Information:
Publications:
| Responsible Party: | Kelvin D Higa, MD; FACS; FASMBS; Professor of Surgery, University of California San Francisco, UCSF Fresno / ALSA Medical Group, Inc. Minimally Invasive Surgery Program |
| ClinicalTrials.gov Identifier: | NCT01040416 History of Changes |
| Other Study ID Numbers: | CMC IRB No. 2008081, U1111-1112-9849 |
| Study First Received: | December 23, 2009 |
| Last Updated: | December 28, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
|
complicated marginal ulcer complex marginal ulcer complication after gastric bypass gastrointestinal hemorrhage |
Additional relevant MeSH terms:
|
Hemorrhage Peptic Ulcer Ulcer Pathologic Processes Duodenal Diseases |
Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Stomach Diseases |
ClinicalTrials.gov processed this record on June 17, 2013