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Completed

NCT Number: NCT04059601

Magnetic Resonance Cholangiography and Intraoperative Cholangiography in 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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Central Finland Central Hospital

Jyväskylä, 40620, Finland

About this study

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:

  • To observe the feasibility of routine preoperative MRCP in acute cholecystitis in Central Finland Central Hospital
  • To study and compare the quality of MRCP and IOC in acute cholecystitis
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinically and radiologically confirmed acute cholecystitis

Exclusion criteria

  • Contraindication for MRCP
  • Patients refuses MRCP

Treatment and study plan

Magnetic resonance cholangiography

Diagnostic Test

preoperative MRCP in acute cholecystitis before cholecystectomy

Intraoperative cholangiography

Diagnostic Test

Intraoperative cholangiography in acute cholecystitis during cholecystectomy

Primary outcomes

  1. MRCP quality

    Time frame: Hospital admission

    Comparing radiology interobserver findings of preoperative MRCP

Secondary outcomes

  1. Success of intraoperative cholangiography

    Time frame: 1 year

    number of performed intraoperative cholangiographies

  2. preoperative MRCP

    Time frame: 1 year

    proportion of patients with bile duct stones in MRCP

  3. Intraoperative cholangiography

    Time frame: During operation

    Number of patients with bile duct stones in intraoperative cholangiography

  4. Conversion

    Time frame: During operation

    proportion of patients with converted laparoscopic cholecystectomy

  5. Timing of cholecystectomy

    Time frame: hours

    Time gap between onset of symptoms and cholecystectomy

  6. Timing of MRCP

    Time frame: hours

    Time gap between hospital admission and MRCP

  7. Complications

    Time frame: 30 days

    Surgical complications

  8. Length of hospital stay

    Time frame: days

    number of days patients spent in hospital

Sponsors and collaborators

Lead sponsor

Jyväskylä Central Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Aug 16, 2019
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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