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To study the effect of placing a stent versus no stent on complications and bile duct stone recurrence rate after clearance in those awaiting gall bladder removal operation

Role of prophylactic biliary stent in reducing the recurrence of choledocholithiasis and biliary complications after stone clearance in patients awaiting cholecystectomy - a Multicentric randomized controlled trial (stone trial). - STONE trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/063685
Enrollment
500
Registered
2024-03-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K807- Calculus of gallbladder and bile duct without cholecystitis

Interventions

Intervention1: Plastic biliary stent: In patients with cholelithiasis with concomitant choledocholithiasis who undergo clearance on ERCP, a prophylactic plastic biliary stent will be placed in the com

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Cases of cholelithiasis with concomitant choledocholithiasis in whom CBD clearance is achieved will be included

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
To compare the biliary and pancreatic complications in the form of cholangitis, cholecystitis, biliary pancreatitis and post ERC pancreatitis between the stent and the no stent groupsTimepoint: From ERC and clearance of stone in ERC till the time period of 3 months irrespective of the timing of cholecystectomy.—

Secondary

MeasureTime frame
- To compare the CDL recurrence rate between the stent and the no stent groups -To compare the need for repeat ERC between the stent and the no stent groupsTimepoint: From ERC and clearance of stone in ERC till the time period of 3 months irrespective of the timing of—

Countries

India

Contacts

Public ContactHarshal S Mandavdhare

Post Graduate Institute of Medical Education and Research

hmandavdhare760@gmail.com9592814877

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026