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Effectiveness of Ursodeoxycholic Acid Use in the Prevention of Gallstone Formation After Sleeve Gastrectomy

Primary Purpose

Cholelithiasis

Status
Unknown status
Phase
Phase 3
Locations
Lebanon
Study Type
Interventional
Intervention
Ursodeoxycholic Acid
Placebo
Gallbladder Ultrasound
Sponsored by
American University of Beirut Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cholelithiasis focused on measuring gallstones, cholelithiasis, sleeve gastrectomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Obese patients (body mass index > 35 kg/m2) undergoing laparoscopic sleeve gastrectomy as a primary treatment for their obesity.
  • No gallstone disease on initial ultrasounds
  • No previous cholecystectomy

Exclusion Criteria:

  • Bariatric patients with gallbladder stones on baseline ultrasound examination.
  • Patients with a previous cholecystectomy

Sites / Locations

  • American University of Beirut Medical CenterRecruiting
  • Makassed General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental

Control

Arm Description

This arm will include 50 patients who, at baseline ultrasound, have no gallbladder pathology and have no previous cholecystectomy. Those patients will be taking an oral drug (Ursodeoxycholic Acid 250mg) twice daily for a period of six months and undergoing a total of three gallbladder ultrasounds (at 6 months, at 12 months, and at 18 months) to check for gallstones.

This arm will include 50 patients who, at baseline ultrasound, have no gallbladder pathology and have no previous cholecystectomy. Those patients will be taking a placebo, that is dispensed from the pharmacy and having the same color as the ursodeoxycholic acid 250mg, twice daily for a period of six months and undergoing a total of three gallbladder ultrasounds (at 6 months, at 12 months, and at 18 months) to check for gallstones.

Outcomes

Primary Outcome Measures

Incidence of gallstone formation after laparoscopic sleeve gastrectomy
Patients in both arms will undergo a total of three abdominal ultrasounds after their bariatric surgery (at 6 months, at 12 months, and at 18 months) to check for gallstones. Once gallstone formation is detected at any of these time points, no additional ultrasounds will be done and the incidence of gallstone formation (Percentage of patients with gallstone formation on ultrasound) will be calculated.

Secondary Outcome Measures

Full Information

First Posted
March 18, 2016
Last Updated
July 12, 2017
Sponsor
American University of Beirut Medical Center
Collaborators
Makassed General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02721862
Brief Title
Effectiveness of Ursodeoxycholic Acid Use in the Prevention of Gallstone Formation After Sleeve Gastrectomy
Official Title
Effectiveness of Ursodeoxycholic Acid Use in the Prevention of Gallstone Formation After Sleeve Gastrectomy: A Prospective Randomized Multicenter Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American University of Beirut Medical Center
Collaborators
Makassed General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized double-blind placebo-controlled trial with a total of 100 patients who are free of gallstones at baseline. The study involves taking an oral drug (Ursodeoxycholic Acid 250mg) or a placebo twice daily for a period of six months and undergoing a total of three abdominal ultrasounds (at 6 months, at 12 months, and at 18 months) to check for gallstones.
Detailed Description
A significant proportion of patients are known to develop gallstones during the phase of rapid weight loss after bariatric surgery. A small percentage of these patients develop symptoms such as abdominal pain, nausea, vomiting, and occasionally more serious symptoms relating to gallbladder disease. Those patients may require surgery for the removal of their gallbladder even though the risks of gallbladder surgery are increased in this patient group. The investigators would like to provide patients who have undergone Laparoscopic Sleeve Gastrectomy a drug that will reduce the risk of developing gallstones during the phase of rapid weight loss after surgery. The drug, Ursodeoxycholic acid, is FDA approved for the reduction in gallstone formation in obese patients undergoing rapid weight loss but has never been proven effective, by randomized controlled studies, in the subgroup of obese patients undergoing Laparoscopic Sleeve Gastrectomy. If proven so, the investigators intend to influence the current practice such that all patients are offered Ursodeoxycholic Acid for the reduction of gallstone formation and their complications following Laparoscopic Sleeve Gastrectomy. In this randomized double-blind placebo-controlled trial, the subjects will be approached by the principal investigator in the clinic with information about taking part in this study, after the decision is made to undergo Laparoscopic Sleeve Gastrectomy for weight loss. The surgeon will answer any questions then and thereafter. The investigators will clarify that participation is voluntary and will not alter routine care whether the patient participates or not. The study involves taking an oral drug (Ursodeoxycholic Acid 250mg) twice daily for a period of six months and undergoing a total of three abdominal ultrasounds (at 6 months, at 12 months, and at 18 months) to check for gallstones. Patients should be gallstone free on an initial ultrasound to satisfy the study inclusion criteria. Ultrasound testing is radiation free and does not pose any additional risk to the subjects. A total of 100 patients need to be recruited. The sample is comparable to current studies and is sufficient to prove or disprove the hypothesis with low risk of error (ref). The patients will either receive placebo or the drug under study, the placebo being dispensed from the pharmacy and having the same color as the ursodeoxycholic acid. The principal investigator and the radiologists measuring the result will be blinded to whether the subject receives the drug or placebo. The study needs to involve human subjects so that the results will be applicable to human subjects. The risk is small because the drug is FDA approved with 13 years post-marketing experience for related indications and is known to be well tolerated. All efforts will be made to protect the privacy and confidentiality of the subjects including protecting their personal information by removing identifiers from data records and storing the identifying codes in a separate location, with all study material under password protection or lock and key at all times.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiasis
Keywords
gallstones, cholelithiasis, sleeve gastrectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
This arm will include 50 patients who, at baseline ultrasound, have no gallbladder pathology and have no previous cholecystectomy. Those patients will be taking an oral drug (Ursodeoxycholic Acid 250mg) twice daily for a period of six months and undergoing a total of three gallbladder ultrasounds (at 6 months, at 12 months, and at 18 months) to check for gallstones.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
This arm will include 50 patients who, at baseline ultrasound, have no gallbladder pathology and have no previous cholecystectomy. Those patients will be taking a placebo, that is dispensed from the pharmacy and having the same color as the ursodeoxycholic acid 250mg, twice daily for a period of six months and undergoing a total of three gallbladder ultrasounds (at 6 months, at 12 months, and at 18 months) to check for gallstones.
Intervention Type
Drug
Intervention Name(s)
Ursodeoxycholic Acid
Other Intervention Name(s)
Ursofalk
Intervention Description
Ursodeoxycholic acid, is FDA approved for the reduction in gallstone formation in obese patients undergoing rapid weight loss.Ursofalk is indicated in the treatment of primary biliary cirrhosis (PBC) and for the dissolution of radiolucent gallstones in patients with a functioning gall bladder.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
The placebo has the same color and size as the ursodeoxycholic acid 250 mg pill
Intervention Type
Radiation
Intervention Name(s)
Gallbladder Ultrasound
Intervention Description
Each patient will undergo a total of three abdominal ultrasounds (at 6 months, at 12 months, and at 18 months after sleeve gastrectomy) to check for gallstones. Patients should be gallstone free on an initial ultrasound to satisfy the study inclusion criteria. Ultrasound testing is radiation free and does not pose any additional risk to the subjects.
Primary Outcome Measure Information:
Title
Incidence of gallstone formation after laparoscopic sleeve gastrectomy
Description
Patients in both arms will undergo a total of three abdominal ultrasounds after their bariatric surgery (at 6 months, at 12 months, and at 18 months) to check for gallstones. Once gallstone formation is detected at any of these time points, no additional ultrasounds will be done and the incidence of gallstone formation (Percentage of patients with gallstone formation on ultrasound) will be calculated.
Time Frame
At 6 months to 18 months after laparoscopic sleeve gastrectomy

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Obese patients (body mass index > 35 kg/m2) undergoing laparoscopic sleeve gastrectomy as a primary treatment for their obesity. No gallstone disease on initial ultrasounds No previous cholecystectomy Exclusion Criteria: Bariatric patients with gallbladder stones on baseline ultrasound examination. Patients with a previous cholecystectomy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ramzi S. Alami, MD, FACS
Phone
+961-1-350000
Ext
5238
Email
ra204@aub.edu.lb
First Name & Middle Initial & Last Name or Official Title & Degree
Bassem Y. Safadi, MD, FACS
Phone
+961-1-350000
Ext
5811
Email
bs21@aub.edu.lb
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramzi S. Alami, Md, FACS
Organizational Affiliation
American University of Beirut Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
American University of Beirut Medical Center
City
Beirut
ZIP/Postal Code
1107 2020
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramzi S. Alami, MD, FACS
Phone
+961-1-350000
Ext
5238
Email
ra204@aub.edu.lb
Facility Name
Makassed General Hospital
City
Beirut
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hayssam Fawal, MD, FACS
Phone
+961-3-824228
Email
hayssamfawal@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effectiveness of Ursodeoxycholic Acid Use in the Prevention of Gallstone Formation After Sleeve Gastrectomy

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