Clinical trial NCT01040416: Endoscopic Therapy for Bleeding Marginal Ulcers After Gastric Bypass
Official title: Endoscopic Therapy for Actively Bleeding Marginal Ulcers: Our Experience After 7,020 Roux-en-Y Gastric Bypass Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bleeding Marginal Ulcer
Keywords: complicated marginal ulcer
complex marginal ulcer
complication after gastric bypass
gastrointestinal hemorrhage
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2009-12-29
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with actively bleeding marginal ulcers after Roux-en-Y gastric bypass (RYGB) surgery.

Brief summary: 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: 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 criteria: 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

Primary outcomes:
measure: Morbidity and mortality, overall
timeFrame: throughout follow-up
measure: re-bleeding, gastrointestinal hemorrhage secondary to marginal ulceration
timeFrame: throughout follow-up
measure: marginal ulcer recurrence
timeFrame: at last follow-up
measure: Symptom resolution, marginal ulcer
timeFrame: at last follow-up
Secondary outcomes:
measure: consumption of blood products
timeFrame: during bleeding-related hospitalization
measure: weight loss expressed as Body Mass Index and Percentage excess weight loss
timeFrame: at the lowest point and yearly intervals
Other outcomes:
Locations:
city: Fresno
country: United States
facility: UCSF Fresno Center for Medical Education and Research
state: California
Study officials:
affiliation: Research Associate, University of California San Francisco
name: Francisco M Tercero, MD
role: STUDY_DIRECTOR
affiliation: Professor of Surgery, University of California San Francisco
name: Kelvin D Higa, MD
role: PRINCIPAL_INVESTIGATOR
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