An interventional study of Group A - Stent exchange if cholecystectomy dated beyond 3 months and Group B - Diagnostic EUS/MRCP/USG abdomen and LFT at 3 months in Choledocholithiasis, sponsored by Asian Institute of Gastroenterology, India. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-29.
Sponsored by Asian Institute of Gastroenterology, India · Not applicable, Interventional, and Diagnostic
We planned this multicenter randomized controlled trial to study the role of a prophylactic biliary stent in recurrence of stones and biliary complications in patients awaiting cholecystectomy after biliary stone clearance
Patients with cholelithiasis can have presence of concomitant choledocholithiasis (CDL) in upto 30%. These stones may remain asymptomatic or cause obstructive jaundice and complications like cholangitis and pancreatitis. In situations where there is a failure of CDL clearance during endoscopic retrograde cholangiography (ERC), biliary stenting is recommended to prevent complications. However, the role of prophylactic biliary stenting in situations where CDL clearance has been achieved, and the patient is awaiting cholecystectomy is debatable. One retrospective study showed benefit while a small prospective study and a retrospective study did not show benefit of prophylactic biliary stenting. Moreover, a randomized controlled trial addressing this question is lacking. Hence, we planned this multicenter randomized controlled trial to study the role of a prophylactic biliary stent in recurrence of stones and biliary complications in patients awaiting cholecystectomy after biliary stone clearance.
109 studies on the registry are indexed under Choledocholithiasis; 24 are open to participants now.
This study's planned enrollment of 480 is above the median of 100 across 76 interventional studies indexed under Choledocholithiasis.
Browse Choledocholithiasis studies →Asian Institute of Gastroenterology, India is the lead sponsor of 135 studies on the registry; 59 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In group A, patients will undergo stent removal and cholangiogram at 3 months of follow up. If we detect recurrent stone/s on cholangiogram, clearance will be done accordingly. If the patient is dated for cholecystectomy beyond 3 months then stent exchange will be done and patient will be followed up till they undergo cholecystectomy. During this waiting period in the later group, patients will undergo monthly follow up for development of any new onset symptoms that are suggestive of biliary pain, pancreatitis, cholangitis and cholecystitis.
Procedure: Group A - Stent exchange if cholecystectomy dated beyond 3 months
In group B, patients will undergo endoscopic ultrasound (EUS) at 3 months of follow up. If we detect recurrent stone/s in EUS then ERC and clearance will be done accordingly. Those who are dated for cholecystectomy beyond 3 months will undergo monthly follow up clinically (biliary pain, pancreatitis, cholangitis and cholecystitis) till they undergo cholecystectomy. Those patient in group B who are unwilling for EUS will be requested to get an magnetic resonance cholangiopancreatography (MRCP) while those unwilling for both EUS/MRCP will be followed up with ultrasound abdomen and liver function test (LFT).
Diagnostic Test: Group B - Diagnostic EUS/MRCP/USG abdomen and LFT at 3 months
Stent removal and cholangiogram and stone clearance (if recurrent stone/s is/are found). Stent exchange if cholecystectomy dated beyond 3 months
Diagnostic EUS/MRCP/USG abdomen and LFT at 3 months to see recurrence of CDL. ERC and stone clearance (if recurrent stone/s found on EUS/MRCP/USG abdomen)
To compare the CDL recurrence rate between the 2 groups
Time frame: 3 Months
To compare the pancreatic complications between the 2 groups -To compare the need for repeat ERC between the 2 groups The outcomes will be compared during the time period of 3 months irrespective of the timing of cholecystectomy.
Time frame: 3 Months
To compare the biliary complications between the 2 groups
Time frame: 3 Months
No study locations are listed for this record.
Start is estimated for Sep 2023; primary completion for Dec 2025, 27 months later.
Of 41 non-industry interventional studies with no phase under Choledocholithiasis, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 36. This study's planned 27 months is above that.
Counting every sponsor, half of 43 studies reached it within 21 months; a quarter within 12 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Asian Institute of Gastroenterology, India →