Endoscopic Therapy for Bleeding Marginal Ulcers After Gastric Bypass (BleedingMU)
|ClinicalTrials.gov Identifier: NCT01040416|
Recruitment Status : Completed
First Posted : December 29, 2009
Last Update Posted : December 29, 2009
|Condition or disease|
|Bleeding Marginal Ulcer|
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.
|Study Type :||Observational|
|Actual Enrollment :||45 participants|
|Official Title:||Endoscopic Therapy for Actively Bleeding Marginal Ulcers: Our Experience After 7,020 Roux-en-Y Gastric Bypass Surgeries|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
|Bleeding marginal ulcer after RYGB|
- Morbidity and mortality, overall [ Time Frame: throughout follow-up ]
- re-bleeding, gastrointestinal hemorrhage secondary to marginal ulceration [ Time Frame: throughout follow-up ]
- marginal ulcer recurrence [ Time Frame: at last follow-up ]
- Symptom resolution, marginal ulcer [ Time Frame: at last follow-up ]
- consumption of blood products [ Time Frame: during bleeding-related hospitalization ]
- weight loss expressed as Body Mass Index and Percentage excess weight loss [ Time Frame: at the lowest point and yearly intervals ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01040416
|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|