Magnetic Resonance Cholangiography and Intraoperative Cholangiography in Acute Cholecystitis

Completed

• Conditions: Acute Cholecystitis

• Registration Number: NCT04059601
• Lead Sponsor: Jyväskylä Central Hospital

Brief Summary

The treatment of choice for acute cholecystitis is cholecystectomy performed as soon as possible after onset of symptoms. Up to 9-22% of patients undergoing cholecystectomy due to cholecystitis have common bile duct stones. Magnetic resonance cholangiopancreatography (MRCP) can aid in technical planning of the operation. Intraoperative cholangiography (IOC) is another method to assess anatomy and stones during operation. There is a lack of quality studies comparing findings of MRCP and IOC and effect on hospital admission.

The aim of this study is to systematically assess the quality of MRCP and IOC in acute cholecystitis, and observe the effect of routine MRCP on surgery outcomes, length of hospital stay, hospital admission costs, and evaluate whether routine IOC could be replaced by MRCP.

Detailed Description

Background

The treatment of choice for acute cholecystitis is cholecystectomy performed as soon as possible after onset of symptoms. Early cholecystectomy within 4 days after onset of symptoms resulted in reduced costs, morbidity and shorter hospital stay than delayed cholecystectomy.

Preoperative magnetic resonance cholangiopancreatography ( MRCP) is usually performed if there is a clinical suspicion of common bile duct ( CBD) stones. CBD stones in acute cholecystitis can be found in up to 9-22% of cholecystectomized patients. MRCP in acute cholecystitis can aid in technical planning of laparoscopic cholecystectomy. The benefit of MRCP is the non-invasiveness of the technique with 85-95% sensitivity and 93%-97% specificity.There is a lack of good-quality prospective studies concerning the findings of MRCP and intraoperative cholangiography (IOC) in acute cholecystitis. The purpose of preoperative diagnosis of CBD stones is to facilitate adequate planning of CBD stone removal, which is preferably performed as a single-stage procedure.

In acute cholecystitis the cystic duct may be obliterated and thus cause cannulation difficulties . In these situations preoperative MRCP may give valuable information if CBD stones are present.

The aims of this study is:

1. To observe the feasibility of routine preoperative MRCP in acute cholecystitis in Central Finland Central Hospital

2. To study and compare the quality of MRCP and IOC in acute cholecystitis

3. To study the impact of preoperative MRCP findings in surgical outcome of laparosocpic cholecystectomy

All patients with clinically and radiologically proven acute cholecystitis during one year (2019) will form the study cohort. Ultrasound and MRCP are performed unless there are no contraindications. The quality of MRCP is systematically and independently evaluated by two experienced radiologists. Laparoscopic or open cholecystectomy is programmed and IOC is performed if feasible. The quality and technical success of IOC is recorded and the c-arm cholangiography is documented and stored in the hospital database. In case of common bile duct stones the operating surgeon will decide the policy of stone removal.

The onset of symptoms, hospital arrival, time from arrival to operation, laboratory values, operative details, 30 day morbidity and postoperative outcome are evaluated.

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-01-03
• Study First Submitted QC: 2019-08-15
• Study First Posted: 2019-08-16
• Primary Completion: 2019-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Clinically and radiologically confirmed acute cholecystitis

Exclusion Criteria

• Contraindication for MRCP
• Patients refuses MRCP

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MRCP quality	Hospital admission	Comparing radiology interobserver findings of preoperative MRCP

Secondary Outcome Measures

Name	Time	Method
Success of intraoperative cholangiography	1 year	number of performed intraoperative cholangiographies
preoperative MRCP	1 year	proportion of patients with bile duct stones in MRCP
Intraoperative cholangiography	During operation	Number of patients with bile duct stones in intraoperative cholangiography
Conversion	During operation	proportion of patients with converted laparoscopic cholecystectomy
Timing of MRCP	hours	Time gap between hospital admission and MRCP
Complications	30 days	Surgical complications
Length of hospital stay	days	number of days patients spent in hospital
Timing of cholecystectomy	hours	Time gap between onset of symptoms and cholecystectomy

Trial Locations

Locations (1)

Central Finland Central Hospital; 🇫🇮 Jyväskylä, Finland