Magnetic Resonance Cholangiography and Intraoperative Cholangiography in Acute Cholecystitis

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Brief Title

Magnetic Resonance Cholangiography and Intraoperative Cholangiography in Acute Cholecystitis

Official Title

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

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 Type

Observational

Primary Outcome

MRCP quality

Secondary Outcome

 Success of intraoperative cholangiography

Condition

Acute Cholecystitis

Intervention

Magnetic resonance cholangiography

Study Arms / Comparison Groups

 Patients with acute cholecystitis
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Diagnostic Test

Estimated Enrollment

120

Start Date

January 1, 2019

Completion Date

January 31, 2020

Primary Completion Date

December 31, 2019

Eligibility Criteria

        Inclusion Criteria:

        • Clinically and radiologically confirmed acute cholecystitis

        Exclusion Criteria:

          -  Contraindication for MRCP

          -  Patients refuses MRCP

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Anne Mattila, MD,PhD, +358142691811, [email protected]

Location Countries

Finland

Location Countries

Finland

Administrative Informations

NCT ID

NCT04059601

Organization ID

Imaging in acute cholecystitis

Responsible Party

Principal Investigator

Study Sponsor

Jyväskylä Central Hospital

Study Sponsor

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

Verification Date

August 2019