Skip to content

Study of comparison of endoscopic and surgical removal of large stones in bile duct

Comparision of Endoscopic and Laparoscopic removal of Large Bile Duct Stone: A Randomized Controlled Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/01/017055
Enrollment
40
Registered
2019-01-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: K838- Other specified diseases of biliary tract

Interventions

Intervention1: Endoscopic Removal: The endoscopic retrograde cholangiopancreatography (ERCP) technique will be carried out as a day care procedure. All the patients will undergo a preanaesthetic check
Olympus, Gurgaon, India). Selective cannulation of the bile duct will be achieved using a wire-guided sphincterotome and a hydrophilic guidewire (Terumo, Trivandrum, India, 260 cm, 0.032-in. diameter)
Erbee, Tuebingen, Germany). The stones will be extracted after fragmenting it with a mechanical lithotripter and subsequently using Dormia basket or stone extraction balloon. In case of these methods
Olympus, Gurgaon, India). The stone will be fragmented using Holmium: YAG laser using 0.5- 1.0 J/pulse with a frequency of 10-20 Hz. A check cholangiogram will be performed to confirm complete clearan

Sponsors

Department of Gastroenterology and Department of Surgery
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with a common bile duct stone of size 1.5 cm or more detected on a magnetic resonance cholangiopancreatography (MRCP) with or without gall stones, both pre and post cholecystectomy will be included in the study.

Exclusion criteria

Exclusion criteria: 1. Presence of acute cholecystitis 2. Presence of acute cholangitis 3. Patients with obstructive jaundice with a serum bilirubin level higher than 10 mg/dl 4. Patients with a CBD diameter less than 10 mm 5. Patients with a history of hepatobiliary surgery other than cholecystectomy 6. Patient with uncorrectable coagulopathy 7. Patient with American Society Anaeathesiology (ASA) class 3 or more 8. Patient refusal to give consent

Design outcomes

Primary

MeasureTime frame
The primary outcome will be a composite of complete removal of stone in the bile duct by laproscopic CBD exploration (LCE) or endoscopic method, need of more than two attempts of ERCP for bile duct clearance or occurrence of major complication.Timepoint: at 1 month

Secondary

MeasureTime frame
1. Complications of the intervention 2. Procedure time in minutes 3. Difficulty of the procedure 4. Hospital stay 5.Cost of the procedure 6. Cost effectivenessTimepoint: at 1 months

Countries

India

Contacts

Public ContactSOUMYA JAGANNATH MAHAPATRA

All India Institute of Medical Sciences

soumyajagannath@yahoo.com09990420767

Outcome results

None listed

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