Magnetic Resonance Cholangiography and Intraoperative Cholangiography in Acute Cholecystitis

March 17, 2021 updated by: Olli Helminen, Jyväskylä Central Hospital

Prospective Study on Impact of Preoperative Magnetic Resonance Cholangiopancreatography (MRCP) and Intraoperative Cholangiography (IOC) in Surgical Treatment of Acute Cholecystitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Jyväskylä, Finland, 40620
        • Central Finland Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients in Central Finland Central Hospital district hospitalized and operated due to acute cholecystitis.

Description

Inclusion Criteria:

• Clinically and radiologically confirmed acute cholecystitis

Exclusion Criteria:

  • Contraindication for MRCP
  • Patients refuses MRCP

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with acute cholecystitis
All patients with acute cholecystitis are included in the study cohort during year 2019. MRCP and IOC will be performed to all patients whenever feasible.
Diagnostic test: Magnetic resonance cholangiography
preoperative MRCP in acute cholecystitis before cholecystectomy
Diagnostic test: Intraoperative cholangiography
Intraoperative cholangiography in acute cholecystitis during cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRCP quality
Time Frame: Hospital admission
Comparing radiology interobserver findings of preoperative MRCP
Hospital admission

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jyväskylä Central Hospital

Investigators

  • Principal Investigator: Anne Mattila, MD,PhD, Central Finland Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

January 3, 2019

First Submitted That Met QC Criteria

August 15, 2019

First Posted (Actual)

August 16, 2019

Study Record Updates

Last Update Posted (Actual)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Imaging in acute cholecystitis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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