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Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after Roux-en-Y gastric bypass and sleeve gastrectomy


- candidate number25561
- NTR NumberNTR6135
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-nov-2016
- Secondary IDsNL59657.048.16 
- Public TitleUrsodeoxycholic acid for the prevention of symptomatic gallstone disease after Roux-en-Y gastric bypass and sleeve gastrectomy
- Scientific TitleUrsodeoxycholic acid for the prevention of symptomatic gallstone disease after Roux-en-Y gastric bypass and sleeve gastrectomy
- ACRONYMUPGRADE
- hypothesisRapid weight loss is a major risk factor for gallstone development. Approximately eleven percent of patients who underwent Roux-en-Y gastric bypass develop symptomatic gallstone disease. After sleeve gastrectomy similar incidences of symptomatic gallstone disease are reported. Gallstone disease can lead to severe complications and often requires hospitalization and surgery. Ursodeoxycholic acid (UDCA) prevents the formation of gallstones after bariatric surgery. However, randomized controlled trials with symptomatic gallstone disease as primary endpoint have not been conducted. Currently, major guidelines make no definite statement about postoperative UDCA prophylaxis and most bariatric centres do not prescribe UDCA.
This study is designed to provide evidence regarding the prophylactic use of UDCA in preventing symptomatic gallstone disease after bariatric surgery.
- Healt Condition(s) or Problem(s) studiedBariatric surgery, gall stones
- Inclusion criteria- Scheduled to undergo Roux-en-Y gastric bypass for morbid obesity
- An intact gallbladder
- Exclusion criteria- Symptomatic gallstone disease already present before RYGB
- Prior bariatric surgery
- Prior gallbladder surgery
- Ascertained or presumptive hypersensitivity to active or excipient ingredients of UDCA.
- Inflammatory bowel disease and other conditions of the small intestine and liver which may interfere with enterohepatic circulation of bile salts (ileal resection and stoma, extra and intra-hepatic cholestasis, severe liver disease)
- Intake of investigational drug within the last 30 days before the screening
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2017
- planned closingdate1-jan-2020
- Target number of participants980
- InterventionsUrsodeoxycholic acid is an artificial bile acid that reduces the ratio of cholesterol to bile salts plus phospholipids in bile, causing desaturation of cholesterol saturated bile. In this study it is prescribed as tablets of 450mg, 2 tablets once daily. The placebo will be similar in look and taste but without active ingredients.

Prior to surgery, an ultrasound of the gallbladder is performed in each patient. Randomization is stratified for the presence of gallstones.
- Primary outcomeThe primary endpoint of this study is symptomatic gallstone disease after 24 months, defined as hospital admission or hospital visit for symptomatic gallstone disease. Hospital visit is a condition, because all patients with noteworthy symptoms will eventually visit the hospital. Mild and self-limiting complaints are not a large burden to the health care system or to the patient, and usually gallstone involvement is not objectified in these patients.

Symptomatic gallstone disease is defined as biliary disease (biliary pancreatitis, acute cholecystitis, choledocholithiasis, cholangitis, or biliairy colics).
- Secondary outcome1. The development of gallstones on ultrasound at 24 months in the gallstone negative group.
2. Number of cholecystectomies in the intervention and the placebo group.
3. Side-effects of UDCA.
4. Therapy compliance.
5. Quality of life, cost-effectiveness, cost-utility and budget impact analyses.
- TimepointsRegular care includes follow-up appointments at 2 and 6 weeks, 4, 6, 12 and 24 months. The study ends after 24 months of follow-up.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. Sylke Haal
- CONTACT for SCIENTIFIC QUERIESDrs. Sylke Haal
- Sponsor/Initiator MC Slotervaart
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Zambon the Netherlands BV, Stichting Klinisch Wetenschappelijk Onderzoek Slotervaartziekenhuis
- Publications
- Brief summaryThe number of bariatric interventions for morbid obesity is increasing rapidly. Rapid weight loss is a major risk factor for gallstone development. Approximately eleven percent of patients who underwent Roux-en-Y gastric bypass develop symptomatic gallstone disease. After sleeve gastrectomy similar incidences of symptomatic gallstone disease are reported. Gallstone disease can lead to severe complications and often requires hospitalization and surgery. Ursodeoxycholic acid (UDCA) prevents the formation of gallstones after bariatric surgery. However, randomized controlled trials with symptomatic gallstone disease as primary endpoint have not been conducted. Currently, major guidelines make no definite statement about postoperative UDCA prophylaxis and most bariatric centres do not prescribe UDCA.
We will conduct a randomized, placebo-controlled, double-blind multicentre trial. The study population consists of consecutive patients undergoing Roux-en-Y gastric bypass or sleeve gastrectomy in the MC Slotervaart, OLVG West and MC Zuiderzee Lelystad. Patients will receive a preoperative ultrasound, randomisation will be stratified for patients already having gallstones and type of surgery. The intervention group will receive UDCA 900mg once daily for six months. The placebo group will receive similar-looking placebo tablets. The primary endpoint is symptomatic gallstone disease after 24 months, defined as admission or hospital visit for symptomatic gallstone disease. Secondary endpoints consist of the development of gallstones on ultrasound at 24 months and side-effects of UDCA. Cost-effectiveness, cost-utility and budget impact analyses will be performed with costs per patient with poor outcome, costs per quality adjusted life year, respectively total reimbursement as primary outcomes.
- Main changes (audit trail)25-juli-2017 -IK:

Inclusiecriteria:
"Scheduled to undergo Roux-en-Y gastric bypass for morbid obesity"
replaced by
"Scheduled to undergo Roux-en-Y gastric bypass or sleeve gastrectomy for morbid obesity"

Interventies:
"Prior to surgery, an ultrasound of the gallbladder is performed in each patient. Randomization is stratified for the presence of gallstones."
replaced by
"Prior to surgery, an ultrasound of the gallbladder is performed in each patient. Randomization is stratified for the presence of gallstones and type of surgery."
- RECORD21-nov-2016 - 25-jul-2017


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