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Preventive Therapy With Ursodiol to Reduce the Incidence of Gallstones Formation in Patients After Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT02319629
Recruitment Status : Recruiting
First Posted : December 18, 2014
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Nasser Sakran, HaEmek Medical Center, Israel

Brief Summary:
Risk factor of cholelithiasis is rapid weight loss after bariatric surgery and change in the gallbladder function which is secondary to surgery. Many observational studies support this fact, and a high incidence of 28% -71% after gastric bypass surgery (RYGB) was reported in them. According to another publication, the incidence of gallbladder diseases is 5-36% after jejunoileal bypass surgery and 2.8-36% after gastric bypass surgery.

Condition or disease Intervention/treatment Phase
Morbid Obesity Drug: URSODIOL Drug: Placebo Not Applicable

Detailed Description:

Study format: Prospective, randomized, blinded study. 266 candidates for sleeve gastrectomy or gastric bypass surgery due to morbid obesity with BMI range of 40-50 and aged 18-65 will be studied.

The patients will be randomly divided into two groups (according to the last digit of the identity card number):

  1. Treatment group will receive preventive therapy with Ursodiol 600 mg per day as of day 10 after the surgery (at the first routine visit after the surgery) and for six months or until the formation of gallstones.
  2. Placebo group will receive placebo as of day 10 after the surgery (at the first routine visit after the surgery) and for six months or until the formation of gallstones.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Preventive Therapy With Ursodiol to Reduce the Incidence of Gallstones Formation in Patients After Bariatric Surgery
Study Start Date : December 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ursodiol

Arm Intervention/treatment
Experimental: URSODIOL - URSODEOXYCHOLIC ACID
300 mg twice a day
Drug: URSODIOL
preventive treatment with Ursolit to reduce the incidence of gallstones formation after bariatric surgery
Other Name: URSODEOXYCHOLIC ACID

Placebo Comparator: placebo
placebo twice a day
Drug: Placebo



Primary Outcome Measures :
  1. Incidence of gallstones formation after bariatric surgery [ Time Frame: six month ]

    - Six months after the surgery the subjects will be invited to re-evaluation of the presence of gallstones using:

    1. Clinical interview: Did he experience epigastric pain? Was he hospitalized with diagnosis of biliary colic or cholecystitis?
    2. US of the upper abdomen to assess the presence of gallstones, gallbladder wall thickening or other disorder.
    3. Blood tests for liver functions and lipids profile



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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
Criteria

Inclusion Criteria:

  • Candidates for sleeve gastrectomy or gastric bypass surgery due to morbid obesity with BMI range of 40 to50.
  • Aged 18 to 65.
  • No presence of gallstones.
  • Patients who have signed the consent form.

Exclusion Criteria:

  • Minors,
  • Pregnant women,
  • Age over 65,
  • Sensitive to Ursodiol,
  • Gallstones,
  • Biliary tract pathologies,
  • Gallbladder wall thickening,
  • Patients after cholecystectomy,
  • Patients participating in another clinical trial.

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 ClinicalTrials.gov identifier (NCT number): NCT02319629


Contacts
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Contact: Nasser Sakran, MD +97246494491 sakran_as@clalit.org.il

Locations
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Israel
surgery department A Recruiting
Afula, Israel
Contact: Nasser Sakran, MD         
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
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Principal Investigator: Nasser Sakran, MD Technion - Israel Institute of Technology, Faculty of Medicine

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Responsible Party: Nasser Sakran, MD, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT02319629     History of Changes
Other Study ID Numbers: EMC- 0129-12 -CTIL
First Posted: December 18, 2014    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Nasser Sakran, HaEmek Medical Center, Israel:
Morbid obesity,
Cholelithiasis
Bariatric surgery
Ursodiol

Additional relevant MeSH terms:
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Obesity, Morbid
Gallstones
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Cholelithiasis
Biliary Tract Diseases
Digestive System Diseases
Cholecystolithiasis
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents