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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01040416
Other study ID # CMC IRB No. 2008081
Secondary ID U1111-1112-9849
Status Completed
Phase N/A
First received December 23, 2009
Last updated December 28, 2009
Start date December 2008
Est. completion date December 2009

Study information

Verified date December 2009
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States UCSF Fresno Center for Medical Education and Research Fresno California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (34)

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Capella JF, Capella RF. Gastro-gastric fistulas and marginal ulcers in gastric bypass procedures for weight reduction. Obes Surg. 1999 Feb;9(1):22-7; discussion 28. — View Citation

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Chin EH, Hazzan D, Sarpel U, Herron DM. Multimedia article. Laparoscopic repair of a perforated marginal ulcer 2 years after gastric bypass. Surg Endosc. 2007 Nov;21(11):2110. Epub 2007 Aug 18. — View Citation

Christou NV, Sampalis JS, Liberman M, Look D, Auger S, McLean AP, MacLean LD. Surgery decreases long-term mortality, morbidity, and health care use in morbidly obese patients. Ann Surg. 2004 Sep;240(3):416-23; discussion 423-4. — View Citation

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Fernández-Esparrach G, Bordas JM, Pellisé M, Gimeno-García AZ, Lacy A, Delgado S, Cárdenas A, Ginès A, Sendino O, Momblán D, Zabalza M, Llach J. Endoscopic management of early GI hemorrhage after laparoscopic gastric bypass. Gastrointest Endosc. 2008 Mar;67(3):552-5. doi: 10.1016/j.gie.2007.10.024. — View Citation

Flum DR, Khan TV, Dellinger EP. Toward the rational and equitable use of bariatric surgery. JAMA. 2007 Sep 26;298(12):1442-4. — View Citation

Gralnek IM, Barkun AN, Bardou M. Management of acute bleeding from a peptic ulcer. N Engl J Med. 2008 Aug 28;359(9):928-37. doi: 10.1056/NEJMra0706113. Review. — View Citation

Gutthann SP, García Rodríguez LA, Raiford DS. Individual nonsteroidal antiinflammatory drugs and other risk factors for upper gastrointestinal bleeding and perforation. Epidemiology. 1997 Jan;8(1):18-24. — View Citation

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).

Hedley AA, Ogden CL, Johnson CL, Carroll MD, Curtin LR, Flegal KM. Prevalence of overweight and obesity among US children, adolescents, and adults, 1999-2002. JAMA. 2004 Jun 16;291(23):2847-50. — View Citation

Higa KD, Boone KB, Ho T, Davies OG. Laparoscopic Roux-en-Y gastric bypass for morbid obesity: technique and preliminary results of our first 400 patients. Arch Surg. 2000 Sep;135(9):1029-33; discussion 1033-4. — View Citation

Higa KD, Boone KB, Ho T. Complications of the laparoscopic Roux-en-Y gastric bypass: 1,040 patients--what have we learned? Obes Surg. 2000 Dec;10(6):509-13. — View Citation

Jordan JH, Hocking MP, Rout WR, Woodward ER. Marginal ulcer following gastric bypass for morbid obesity. Am Surg. 1991 May;57(5):286-8. — View Citation

Lublin M, McCoy M, Waldrep DJ. Perforating marginal ulcers after laparoscopic gastric bypass. Surg Endosc. 2006 Jan;20(1):51-4. Epub 2005 Dec 7. — View Citation

Madan AK, DeArmond G, Ternovits CA, Beech DJ, Tichansky DS. Laparoscopic revision of the gastrojejunostomy for recurrent bleeding ulcers after past open revision gastric bypass. Obes Surg. 2006 Dec;16(12):1662-8. — View Citation

McTigue KM, Harris R, Hemphill B, Lux L, Sutton S, Bunton AJ, Lohr KN. Screening and interventions for obesity in adults: summary of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2003 Dec 2;139(11):933-49. — View Citation

Meguid MM, Glade MJ, Middleton FA. Weight regain after Roux-en-Y: a significant 20% complication related to PYY. Nutrition. 2008 Sep;24(9):832-42. doi: 10.1016/j.nut.2008.06.027. Review. — View Citation

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.

Nguyen NT, Hinojosa MW, Gray J, Fayad C. Reoperation for marginal ulceration. Surg Endosc. 2007 Nov;21(11):1919-21. Epub 2007 Aug 19. Review. — View Citation

Nguyen NT, Longoria M, Chalifoux S, Wilson SE. Gastrointestinal hemorrhage after laparoscopic gastric bypass. Obes Surg. 2004 Nov-Dec;14(10):1308-12. — View Citation

Nguyen NT. Reoperations and revisions in bariatric surgery. Surg Endosc. 2007 Nov;21(11):1907-8. Epub 2007 Sep 8. — View Citation

Patel RA, Brolin RE, Gandhi A. Revisional operations for marginal ulcer after Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2009 May-Jun;5(3):317-22. doi: 10.1016/j.soard.2008.10.011. Epub 2008 Nov 6. — View Citation

Sacks BC, Mattar SG, Qureshi FG, Eid GM, Collins JL, Barinas-Mitchell EJ, Schauer PR, Ramanathan RC. Incidence of marginal ulcers and the use of absorbable anastomotic sutures in laparoscopic Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2006 Jan-Feb;2(1):11-6. — View Citation

Santry HP, Gillen DL, Lauderdale DS. Trends in bariatric surgical procedures. JAMA. 2005 Oct 19;294(15):1909-17. — View Citation

Sanyal AJ, Sugerman HJ, Kellum JM, Engle KM, Wolfe L. Stomal complications of gastric bypass: incidence and outcome of therapy. Am J Gastroenterol. 1992 Sep;87(9):1165-9. — View Citation

Sapala JA, Wood MH, Sapala MA, Flake TM Jr. Marginal ulcer after gastric bypass: a prospective 3-year study of 173 patients. Obes Surg. 1998 Oct;8(5):505-16. — View Citation

Sjöström L, Narbro K, Sjöström CD, Karason K, Larsson B, Wedel H, Lystig T, Sullivan M, Bouchard C, Carlsson B, Bengtsson C, Dahlgren S, Gummesson A, Jacobson P, Karlsson J, Lindroos AK, Lönroth H, Näslund I, Olbers T, Stenlöf K, Torgerson J, Agren G, Carlsson LM; Swedish Obese Subjects Study. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med. 2007 Aug 23;357(8):741-52. — View Citation

St Jean MR, Dunkle-Blatter SE, Petrick AT. Laparoscopic management of perforated marginal ulcer after laparoscopic Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2006 Nov-Dec;2(6):668. — View Citation

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).

* Note: There are 34 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Morbidity and mortality, overall throughout follow-up Yes
Primary re-bleeding, gastrointestinal hemorrhage secondary to marginal ulceration throughout follow-up Yes
Primary marginal ulcer recurrence at last follow-up Yes
Primary Symptom resolution, marginal ulcer at last follow-up No
Secondary consumption of blood products during bleeding-related hospitalization No
Secondary weight loss expressed as Body Mass Index and Percentage excess weight loss at the lowest point and yearly intervals No