Bleeding Marginal Ulcer Clinical Trial
Official title:
Endoscopic Therapy for Actively Bleeding Marginal Ulcers: Our Experience After 7,020 Roux-en-Y Gastric Bypass Surgeries
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.
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.
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Observational Model: Cohort, Time Perspective: Retrospective