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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - Patients will undergo stent removal and cholangiogram at 3 months of follow up | Active Comparator | 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. |
|
| Group B - Patients will undergo endoscopic ultrasound (EUS) at 3 months of follow up. | Sham Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group A - Stent exchange if cholecystectomy dated beyond 3 months | Procedure | Stent removal and cholangiogram and stone clearance (if recurrent stone/s is/are found). Stent exchange if cholecystectomy dated beyond 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the CDL recurrence rate between the 2 groups | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 Months | |
| To compare the biliary complications between the 2 groups |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D042883 | Choledocholithiasis |
| ID | Term |
|---|---|
| D003137 | Common Bile Duct Diseases |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| Group B - Diagnostic EUS/MRCP/USG abdomen and LFT at 3 months | Diagnostic Test | 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) |
|
| 3 Months |
| D002769 | Cholelithiasis |