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

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01040416
First received: December 23, 2009
Last updated: December 28, 2009
Last verified: December 2009
  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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Study Population

Patients with actively bleeding marginal ulcers after Roux-en-Y gastric bypass (RYGB) surgery.

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01040416

Locations
United States, California
UCSF Fresno Center for Medical Education and Research
Fresno, California, United States, 93701
Sponsors and Collaborators
University of California, San Francisco
Investigators
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:
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).
Patel RA, Brolin RE, Gandhi AD. Revisional operations for marginal ulcer after Roux-en-Y gastric bypass. Surg Obes Relat Dis 2008; 4(3): 309 (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.

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:
Ulcer
Hemorrhage
Peptic Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on September 18, 2014