CholelithiasisPhase 3NCT02721862
Effectiveness of Ursodeoxycholic Acid Use in the Prevention of Gallstone Formation After Sleeve Gastrectomy
A Phase 3 study testing Ursodeoxycholic Acid and Gallbladder Ultrasound in people with Cholelithiasis, run by American University of Beirut Medical Center at 2 sites in Lebanon.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cholelithiasis
- What is being tested?
- Ursodeoxycholic Acid and Gallbladder Ultrasound
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesLebanon
- Study dates
- Mar 2016to Mar 2019
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Bariatric patients with gallbladder stones on baseline ultrasound examination.
- Patients with a previous cholecystectomy
Trial locations and contacts
2 sites in 1 country.
Lebanon2 sites, 2 recruiting
- Recruiting
American University of Beirut Medical Center
Beirut, 1107 2020
Ramzi S. Alami, MD, FACS, +961-1-350000 ext. 5238, ra204@aub.edu.lb
- Recruiting
Makassed General Hospital
Beirut
Hayssam Fawal, MD, FACS, +961-3-824228, hayssamfawal@gmail.com
About this study
Official title: Effectiveness of Ursodeoxycholic Acid Use in the Prevention of Gallstone Formation After Sleeve Gastrectomy: A Prospective Randomized Multicenter Placebo-Controlled Trial
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.
Read the 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.
- Conditions
- Cholelithiasis
- Being tested
- Ursodeoxycholic Acid, Placebo, Gallbladder Ultrasound
- Keywords
- gallstones, cholelithiasis, sleeve gastrectomy
- Medical subject headings
- Cholelithiasis, Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ursodeoxycholic AcidDrug
Also called Ursofalk
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.
PlaceboDrug
Also called Sugar pill
The placebo has the same color and size as the ursodeoxycholic acid 250 mg pill
Gallbladder UltrasoundRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 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. Receives: Drug: Ursodeoxycholic Acid; Radiation: Gallbladder Ultrasound |
| Control | Placebo comparator | 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. Receives: Drug: Placebo; Radiation: Gallbladder Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6 months to 18 months after laparoscopic sleeve gastrectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2018 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Makassed General Hospital
- Responsible party
- Principal investigator, Dr. Ramzi Alami, American University of Beirut Medical Center
- Investigators
- Ramzi S. Alami, Md, FACS, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721862
- Sponsor's protocol ID
- SUR.RA.01
- Status last verified
- Mar 2016
- First submitted
- 18 Mar 2016
- Last updated
- 14 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ursodeoxycholic Acid Use in the Prevention of Gallstone Formation After Sleeve Gastrectomy: A Prospective Randomized Multicenter Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT02721862
- Acronym / sponsor ID
- SUR.RA.01
- Conditions
- Cholelithiasis
- Keywords
- gallstones, cholelithiasis, sleeve gastrectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Collaborators
- Makassed General Hospital
- Study start
- Mar 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 29 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Ursodeoxycholic Acid, Radiation: Gallbladder UltrasoundThis 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. |
| Control | Placebo comparator | Drug: Placebo, Radiation: Gallbladder UltrasoundThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Bariatric patients with gallbladder stones on baseline ultrasound examination.
- Patients with a previous cholecystectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ursodeoxycholic AcidAlso: UrsofalkUrsodeoxycholic 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. | Drug | Experimental |
| PlaceboAlso: Sugar pillThe placebo has the same color and size as the ursodeoxycholic acid 250 mg pill | Drug | Control |
| Gallbladder UltrasoundEach 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. | Radiation | Control, Experimental |
Primary outcome
Incidence of gallstone formation after laparoscopic sleeve gastrectomy
Time frame: At 6 months to 18 months 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Cholelithiasis
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Active, not recruiting
Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
Acute Pancreatitis, Cholelithiasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramzi S. Alami, Md, FACS principal investigator
American University of Beirut Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ursodeoxycholic Acid and Gallbladder Ultrasound in people with Cholelithiasis, run by American University of Beirut Medical Center at 2 sites in Lebanon.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lebanon. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ramzi S. Alami, MD, FACS (+961-1-350000 ext. 5238, ra204@aub.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of gallstone formation after laparoscopic sleeve gastrectomy (time frame: At 6 months to 18 months after laparoscopic sleeve gastrectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2017.