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Marginal UlcerChronicMUNCT01041079

Chronic Marginal Ulcers After Gastric Bypass

An observational study of Marginal Ulcer and Chronic Ulcer Disease, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the feasibility, safety, and efficacy of revision gastroplasty along with other adjunct procedures in the treatment of intractable / chronic marginal ulcers after Roux-en-Y gastric bypass. Read more about this study

Who is it for?
Ages 18 to 65 years
How many people
50 participants
Where
1 siteUnited States
Study dates
Dec 2008to Dec 2009
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients after Roux-en-Y gastric bypass for clinically severe obesity complicated with intractable or chronic marginal ulcer disease

Who may be able to join

  • Chronic/Intractable, either recurrent or persistent, marginal ulcers after Roux-en-Y gastric bypass surgery for clinically severe obesity

Who cannot join

  • Chronic or Intractable marginal ulcer after other bariatric procedures
  • Revision or re-operation by open approach
  • missing records and/or unreachable patients with scant information for analysis

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California San Francisco, Department of Surgery/Fresno Medical Education Program

    Fresno, California, 93701

Other trials in United States

About this study

Official title: Laparoscopic Revision Gastric Bypass Surgery for Chronic Marginal Ulcers: a 10 Year Experience

The purpose of this study is to determine the feasibility, safety, and efficacy of revision gastroplasty along with other adjunct procedures in the treatment of intractable / chronic marginal ulcers after Roux-en-Y gastric bypass. A secondary aim is the identification of good and poor outcome predictors after revisional strategies for intractable or chronic marginal ulcer.

Read the detailed description

The epidemic of overweight and obesity in the United States of America along with its comorbidities continues to expand. Bariatric surgery has demonstrated to be the most effective and sustained method to control severe obesity and its comorbidities. For instance, type 2 diabetes mellitus was completely resolved in 76.8%, systemic arterial hypertension was resolved in 61.7%, dyslipidemia improved in 70% and obstructive sleep apnea-hypopnea syndrome was resolved in 85.7%. Furthermore, bariatric surgery significantly increases life expectancy (89%) and decreases overall mortality (30-40%), particularly deaths from diabetes, heart disease, and cancer. Lastly, preliminary evidence about downstream savings associated with bariatric surgery offset the initial costs in 2 to 4 years.

Since 1998, there has been a substantially progressive increase in bariatric surgery. In 2005, the ASMBS reported that 81% of bariatric procedures were approached laparoscopically and in 2007, 205,000 people had bariatric surgery in the United States from which approximately 80% of these were Gastric Bypass. Moreover, there is a mismatch between eligibility and receipt of bariatric surgery with just less than 1% of the eligible population being treated for morbid obesity through bariatric surgery. Along with the increasing number of elective primary weight loss procedures, up to 20% of post RYGB patients cannot sustain their weight loss beyond 2 to 3 years after the primary bariatric procedure. Thus, revisional surgery for poor weight loss and re-operations for technical or mechanical complications will rise in a parallel manner.

A common late complication after gastric bypass surgery is marginal ulceration, an ulcer at the margins of the gastrojejunostomy on the jejunal side. Its incidence after RYGB ranges from as low as 0.6 to as high as 16%. After 1,040 laparoscopic RYGB surgeries, the incidence rate, in our hands, is 1.4% and mainly related to NSAID´s use. In observational cohort studies, 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, when perforation, obstruction, penetration, bleeding and/or intractability presents, complex or complicated ulcer disease, warrants surgical intervention.

The intestinal mucosa is not typically exposed to gastric acid, which is neutralized by the alkaline biliopancreatic secretions. The jejunal mucosa has no natural barriers; when exposed to gastric acid, it ulcerates easily. Capella \& Capella demonstrated that transecting the gastric segments significantly reduce staple-line dehiscence; this is the so-called divided gastric bypass. In the retrospective analysis of their consecutive series, the incidence for gastro-gastric fistula (GGF) formation after undivided gastric bypass (GBP) was 23%, after a partially divided GBP was 19%, after a completely divided GBP was 2% and after complete transection with interposition of the jejunal limb was 0% (p <0.001). MacLean et al confirmed that divided primary gastric bypass decreases GGF formation (29% vs. 3%). Also, patients who developed marginal ulcers had a lower pH as well as a greater time with a pH less than 2 correlating 100% with the presence of GGF; closure of the GGF increased the pH in the pouch with subsequent healing of the marginal ulcer.

An unusually large gastric pouch (such as horizontal pouches, retained fundus, long lesser curvature based pouches or enlarged after initially being sized adequately) contain more acid-producing parietal cells. Increased acid production in the pouch carries the risk of developing marginal ulcers. Acid secretion in the small pouch after RYGB is virtually absent. Smith et al measured basal and pentagastrin-stimulated gastric acid secretion from the pouch were significantly lower compared to age and sex-matched controls. Likewise, MacLean et al reported a significantly lower pH \& greater time with pH <2 in the gastric pouches of marginal ulcers and/or GGF patients after RYGB compared to non-complicated RYGB controls. Thus, creating a esophagojejunostomy would solve the gastric acid factor for developing marginal ulcers however the high incidence of anastomotic failure and unknown weight loss results are prohibitive for this approach. Sapala et al created a micro-pouch or cardiojejunostomy to decrease at maximum the parietal cell mass with a low incidence of marginal ulcers (0.01% at 1 years of follow-up) as well as to limit the pouch dilation. By Histopathology with a semi-quantitative approach, Gustavsson et al reported less acid-producing parietal cells within smaller pouches. With his next study (n=12), Gustavsson et al, demonstrated a significantly higher time exposure to a pH<4 in patients with marginal ulcer after RYGB (4x3cm pouch) compared to controls (p< 0.01). Furthermore, after downsizing the pouch, repeated pH-metry showed the % of time with pH <4 declined from 100% prior to 6% after revisionary surgery.

The anastomotic techniques influence the incidence of marginal ulcers. Capella \& Capella reported a consecutive series with significant decrement from 5.1% to 1.5% (p< 0.001) after switching from a stapled to a hand-sewn anastomosis. Likewise, after changing from an inner layer of absorbable suture and an outer layer of nonabsorbable material to a double-layer of absorbable suture the incidence rate improved from 1.6% to 0%. Dr Schauer´s group confirmed a significant improvement in the incidence rate of MU from a 2.6% with the use of nonabsorbable suture for the outer layer to 1.3% after the change to absorbable suture for both layers (p < 0.001).

Local ischemia, in the immediate postoperative period, is probably secondary to technical reasons. Fundamental aspects for decreasing tension and local ischemia at the gastrojejunostomy are dissection of the tissues around the pouch without devascularizing the lesser curvature and complete mobilization of a well-perfused Roux limb.

In epidemiological, clinical and experimental studies, NSAID´s have been identified as one of the three major risk factors for PUD. Wilson et al found NSAID´s consumption to significantly increase the risk for marginal ulcer following RYGB (adjusted OR 11.5, 95%CI 4.8-28).

In epidemiological, clinical and experimental studies, Tobacco is another major risk factor for PUD. Smoking carries an overall relative risk of 2.2 (95%CI, 2.0-2.3).

Helicobacter pylori (H pylori) infection carries an overall relative risk of 3.3 (95%CI, 2.6-4.4) for developing PUD. A synergistic relationship exists between H pylori infection and NSAID´s consumption for developing PUD with an overall risk of 3.5 (95%CI, 1.26-9.96) compared to either H pylori or NSAID´s negative individuals. In Papasavas et al study, preoperative H. pylori testing with prophylactic eradication did not decrease the incidence of MU or erosive pouch gastritis.

The pathophysiological mechanisms of damage to the gastric mucosa of ethanol and alcoholic beverages are poorly understood. There are no studies available about the effect of alcohol on marginal ulcer development after RYGB.

Cocaine use is responsible for approximately 143,000 Emergency Department visits annually; 19% of American, between 18 to 25 years old, have used cocaine: more than 1% of the Americans use cocaine at least once a week; and approximately 50% of all drug-related deaths were secondary to Cocaine. The temporal association between smoking cocaine (crack) and GI tract manifestations include ulceration, perforation, visceral infarction, and retroperitoneal fibrosis.

Re-operative strategies for addressing chronic marginal ulcers after gastric bypass have been scarcely described and mostly are reports of a case or small series of cases. The revisional strategies described are I) ulcer excision with revision of the gastrojejunostomy and gastric transection if needed, II) ulcer excision with pouch downsizing and redo of gastrojejunostomy, III) ulcer excision with resection of the ischemic Roux limb segment, and IV) ulcer excision and reversal. The possible adjuvant procedures includes I) proximal remnant gastrectomy (partial gastrectomy), and II) vagotomy.

In summary, there is scant information about 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.

Keywords
ulcer disease, marginal ulcer, morbidity of gastric bypass, late morbidity of gastric bypass, chronic abdominal pain, GI hemorrhage, Perforation, Penetration, Obstruction
Medical subject headings
Peptic Ulcer, Gastrointestinal Hemorrhage, Bites and Stings

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01041079
Study groupRoleWhat they receive
Chronic marginal ulcer after RYGBPatients with intractable or chronic marginal ulcer disease after gastric bypass complaining of abdominal pain, GI bleeding, obstruction, perforation and penetration. Sometimes with other associated diagnosis such as narcotic and tobacco dependence, protein-calorie malnutrition, excessive weight loss, poor pouch emptying syndrome, weight regain, inadequate initial weight loss, severe dumping syndrome among others.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Morbidity and mortality

    Measured: at discharge, 1 week, 3 weeks, 8 weeks, 3 months, 6 months, 1 year and annually thereafter for up to 4 years

  2. Weight loss expressed as Body Mass Index and Percentage excess weight loss

    Measured: at 6 months, 1 year and annually thereafter for up to 4 years

  3. Remission or improvement of marginal ulcer-related symptoms

    Measured: at 6 months, 1 year and annually thereafter for up to 4 years

  4. Remission or improvement of comorbidities

    Measured: at 6 months, 1 year and annually thereafter for up to 4 years

Secondary outcomes (2)
  1. Length of operative time which is defined as the time duration of operation measured in minutes from the first skin incision to the final closure of the skin incision

    Measured: It is measured in minutes from the first skin incision to the final closure of the skin incision at the time of revisional surgery under study. It is a transoperative measure of outcome of the surgery under study

  2. Length of Hospital Stay which is a measured of surgical recovery quantified and reported in days. It is a hospital pre-discharge traditional measure of outcome.

    Measured: It is measured in days from the admission date to the discharge date for the hospitalization pertaining to revisional surgery under study.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2009 (estimated)
  2. Study startDec 2008
  3. Primary completionDec 2009
  4. Study completionDec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01041079
Sponsor's protocol ID
CMC IRB No. 2008078
Other IDs
U1111-1112-9755
Acronym
ChronicMU
Status last verified
Dec 2009
First submitted
25 Dec 2009
Last updated
1 Jan 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • 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. doi: 10.1001/archsurg.135.9.1029.

    PubMed 10982506
  • 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. doi: 10.1001/jama.291.23.2847.

    PubMed 15199035
  • 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. doi: 10.7326/0003-4819-139-11-200312020-00013.

    PubMed 14644897
  • Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724.

    PubMed 15479938
  • 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. doi: 10.1097/01.sla.0000137343.63376.19.

    PubMed 15319713
  • Adams TD, Gress RE, Smith SC, Halverson RC, Simper SC, Rosamond WD, Lamonte MJ, Stroup AM, Hunt SC. Long-term mortality after gastric bypass surgery. N Engl J Med. 2007 Aug 23;357(8):753-61. doi: 10.1056/NEJMoa066603.

    PubMed 17715409
  • Sjostrom L, Narbro K, Sjostrom 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, Lonroth H, Naslund I, Olbers T, Stenlof 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. doi: 10.1056/NEJMoa066254.

    PubMed 17715408
  • Cremieux PY, Buchwald H, Shikora SA, Ghosh A, Yang HE, Buessing M. A study on the economic impact of bariatric surgery. Am J Manag Care. 2008 Sep;14(9):589-96.

    PubMed 18778174
  • Santry HP, Gillen DL, Lauderdale DS. Trends in bariatric surgical procedures. JAMA. 2005 Oct 19;294(15):1909-17. doi: 10.1001/jama.294.15.1909.

    PubMed 16234497
  • Flum DR, Khan TV, Dellinger EP. Toward the rational and equitable use of bariatric surgery. JAMA. 2007 Sep 26;298(12):1442-4. doi: 10.1001/jama.298.12.1442. No abstract available.

    PubMed 17895461
  • 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.

    PubMed 18725080
  • Nguyen NT. Reoperations and revisions in bariatric surgery. Surg Endosc. 2007 Nov;21(11):1907-8. doi: 10.1007/s00464-007-9572-6. Epub 2007 Sep 8. No abstract available.

    PubMed 17828427
  • 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. doi: 10.1381/096089298765554061.

    PubMed 9819081
  • 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. doi: 10.1381/096089200321593706.

    PubMed 11175957
  • 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.

    PubMed 1519574

Questions about this trial

What is this clinical trial studying?

An observational study of Marginal Ulcer and Chronic Ulcer Disease, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Morbidity and mortality (time frame: at discharge, 1 week, 3 weeks, 8 weeks, 3 months, 6 months, 1 year and annually thereafter for up to 4 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01041079, which also lists 40 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2010; AzTrials last refreshed its copy on 30 Oct 2026.

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