Management of CBD Stones At Laparoscopic Cholecystectomy

Management of CBD stones at laparoscopic cholecystectomy: A NSW collaborative prospective randomised trial to assess the value of transcystically inserted CBD stents to facilitate post-operative ERCP.

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000040662

Enrollment

340

Registered

2005-07-25

Start date

2004-07-19

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

This study is designed to assess whether a new technique called facilitated endoscopic retrograde cholangiopancreatography (ERCP) is or is not superior to conventional ERCP to remove stones found in the bile duct at the time of laparoscopic cholecystectomy. ERCP is an endoscopic procedure used to facilitate the radiological examination and subsequent manipulation of the common bile duct (eg. opening it up, which is called sphincterotomy). Both facilitated and conventional ERCP are performed as a separate procedure after the initial gallbladder surgery. This is a comparative study of these two techniques in a randomised clinical trial. The aim of this randomised clinical trial is to enable surgeons to decide whether placement of a plastic stent at the time of laparoscopic cholecystectomy will improve the success rate and safety of subsequent ERCP and sphincterotomy.

Interventions

Facilitated' (placement of a stent at the time of laparoscopic cholecystectomy) endoscopic retrograde cholangiopancreatography (ERCP).

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to -2147483648 No limit

Healthy volunteers

Inclusion criteria

The patient must be able to give informed consent preoperatively (i.e. elective procedures only). Patients at higher than normal risk of having CBD stones identified at OC: a CBD stone identified at ultrasound; a wide CBD (>6mm) at ultrasound; previous, recent, current cholangitis, jaundice, or biliary pancreatitis; abnormal AST and ALT levels (>2 times normal).

Exclusion criteria

Pregnancy at time of surgery. Patients not fit for surgery. For example: those with acute cholecystitis or persistent obstructive jaundice; patients who have had a previous ERCP and sphincterotomy; those in whom intervention was not technically possible (eg. previous Billroth II gastrectomy).

Outcome results