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Endoscopic Therapy for Bleeding Marginal Ulcers After Gastric Bypass (BleedingMU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01040416
Recruitment Status : Completed
First Posted : December 29, 2009
Last Update Posted : December 29, 2009
Information provided by:
University of California, San Francisco

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.

Condition or disease
Bleeding Marginal Ulcer

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.

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Study Type : Observational
Actual Enrollment : 45 participants
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
Study Start Date : December 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Endoscopy

Bleeding marginal ulcer after RYGB

Primary Outcome Measures :
  1. Morbidity and mortality, overall [ Time Frame: throughout follow-up ]
  2. re-bleeding, gastrointestinal hemorrhage secondary to marginal ulceration [ Time Frame: throughout follow-up ]
  3. marginal ulcer recurrence [ Time Frame: at last follow-up ]
  4. Symptom resolution, marginal ulcer [ Time Frame: at last follow-up ]

Secondary Outcome Measures :
  1. consumption of blood products [ Time Frame: during bleeding-related hospitalization ]
  2. weight loss expressed as Body Mass Index and Percentage excess weight loss [ Time Frame: at the lowest point and yearly intervals ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01040416

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United States, California
UCSF Fresno Center for Medical Education and Research
Fresno, California, United States, 93701
Sponsors and Collaborators
University of California, San Francisco
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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
Additional Information:
Wheeler AA, Matz ST, Fearing NM et al. Laparoscopic repair of perforated marginal ulcer following laparoscopic Roux-en-Y gastric bypass: a case series. Surg Endosc 2008; 22: S198 (Abstract).
Hata JA, DeMaria EJ, Portenier DD et al. Marginal ulcer after 1,792 laparoscopic Roux-en-Y gastric bypass (LRYGB) procedures: incidence, medical and surgical treatment and complications. Surg Obes Relat Dis 2008; 4(3):308-9 (Abstract).
Nguyen NT, Hinojosa MW, Gray J et al. (2008). Gastrointestinal bleeding after Roux-en-Y gastric bypass. In Weight loss surgery: A multidisciplinary approach (pp. 401-4). Edgemont, PA: Matrix Medical Communications.

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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 Identifier: NCT01040416    
Other Study ID Numbers: CMC IRB No. 2008081
U1111-1112-9849 ( Other Identifier: World Health Organization, Universal Trial Number )
First Posted: December 29, 2009    Key Record Dates
Last Update Posted: December 29, 2009
Last Verified: December 2009
Keywords provided by University of California, San Francisco:
complicated marginal ulcer
complex marginal ulcer
complication after gastric bypass
gastrointestinal hemorrhage
Additional relevant MeSH terms:
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Peptic Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases