Morbid ObesityNCT02319629
Preventive Therapy With Ursodiol to Reduce the Incidence of Gallstones Formation in Patients After Bariatric Surgery
A study testing URSODIOL in people with Morbid Obesity, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- URSODIOL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 266 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2014to Dec 2018
- Phase
- Interventional
- 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
Who may be able to join
- 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.
Who cannot join
- Minors,
- Pregnant women,
- Age over 65,
- Sensitive to Ursodiol,
- Gallstones,
- Biliary tract pathologies,
Show all 9Show fewer
- Gallbladder wall thickening,
- Patients after cholecystectomy,
- Patients participating in another clinical trial.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
surgery department A
Afula
Nasser Sakran, MD
About this study
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.
Read the 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):
- 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.
- 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.
- Conditions
- Morbid Obesity
- Being tested
- URSODIOL, Placebo
- Keywords
- Morbid obesity,, Cholelithiasis, Bariatric surgery, Ursodiol
- Medical subject headings
- Obesity, Morbid, Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
URSODIOLDrug
Also called URSODEOXYCHOLIC ACID
preventive treatment with Ursolit to reduce the incidence of gallstones formation after bariatric surgery
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| URSODIOL - URSODEOXYCHOLIC ACID | Experimental | 300 mg twice a day Receives: Drug: URSODIOL |
| placebo | Placebo comparator | placebo twice a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of gallstones formation after bariatric surgery
- Six months after the surgery the subjects will be invited to re-evaluation of the presence of gallstones using:
- Clinical interview: Did he experience epigastric pain? Was he hospitalized with diagnosis of biliary colic or cholecystitis?
- US of the upper abdomen to assess the presence of gallstones, gallbladder wall thickening or other disorder.
- Blood tests for liver functions and lipids profile
Measured: six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nasser Sakran, HaEmek Medical Center, Israel
- Investigators
- Nasser Sakran, MD, Principal investigator, Technion - Israel Institute of Technology, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319629
- Sponsor's protocol ID
- EMC- 0129-12 -CTIL
- Status last verified
- May 2018
- First submitted
- 3 Dec 2014
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Sakran N, Dar R, Assalia A, Neeman Z, Farraj M, Sherf-Dagan S, Gralnek IM, Hazzan R, Mokary SE, Nevo-Aboody H, Dola T, Kaplan U, Hershko D. The use of Ursolit for gallstone prophylaxis following bariatric surgery: a randomized-controlled trial. Updates Surg. 2020 Dec;72(4):1125-1133. doi: 10.1007/s13304-020-00850-2. Epub 2020 Jul 14.
PubMed 32666477
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Therapy With Ursodiol to Reduce the Incidence of Gallstones Formation in Patients After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02319629
- Acronym / sponsor ID
- EMC- 0129-12 -CTIL
- Conditions
- Morbid Obesity
- Keywords
- Morbid obesity,, Cholelithiasis, Bariatric surgery, Ursodiol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 18 Dec 2014 (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.
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.
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):
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| URSODIOL - URSODEOXYCHOLIC ACID | Experimental | Drug: URSODIOL300 mg twice a day |
| placebo | Placebo comparator | Drug: Placeboplacebo twice a day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- Minors,
- Pregnant women,
- Age over 65,
- Sensitive to Ursodiol,
- Gallstones,
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 |
|---|---|---|
| URSODIOLAlso: URSODEOXYCHOLIC ACIDpreventive treatment with Ursolit to reduce the incidence of gallstones formation after bariatric surgery | Drug | URSODIOL - URSODEOXYCHOLIC ACID |
| Placebo | Drug | placebo |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
- Derived from this study: PubMed 32666477Sakran N, Dar R, Assalia A, Neeman Z, Farraj M, Sherf-Dagan S, Gralnek IM, Hazzan R, Mokary SE, Nevo-Aboody H, Dola T, Kaplan U, Hershko D. The use of Ursolit for gallstone prophylaxis following bariatric surgery: a randomized-controlled trial. Updates Surg. 2020 Dec;72(4):1125-1133. doi: 10.1007/s13304-020-00850-2. Epub 2020 Jul 14.
- Individual participant dataSharing planned: Yes
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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.
Nasser Sakran, MD principal investigator
Technion - Israel Institute of Technology, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing URSODIOL in people with Morbid Obesity, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 4 inclusion and 9 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 17 May 2018. 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 Israel. 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.
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 Nasser Sakran, MD (+97246494491, sakran_as@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of gallstones formation after bariatric surgery (time frame: six month). 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 NCT02319629, which also lists 1 linked publication.
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 17 May 2018.