Clinical trial NCT04059601: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Cholecystitis
Keywords: common bile duct stones
cholecystectomy
Lead sponsor: Jyväskylä Central Hospital
Sponsor class: OTHER
First posted: 2019-08-16
Enrollment: 180
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients in Central Finland Central Hospital district hospitalized and operated due to 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.

Eligibility criteria: Inclusion Criteria:

• Clinically and radiologically confirmed acute cholecystitis

Exclusion Criteria:

* Contraindication for MRCP
* Patients refuses MRCP

Primary outcomes:
measure: MRCP quality
timeFrame: Hospital admission
Secondary outcomes:
measure: Success of intraoperative cholangiography
timeFrame: 1 year
measure: preoperative MRCP
timeFrame: 1 year
measure: Intraoperative cholangiography
timeFrame: During operation
measure: Conversion
timeFrame: During operation
measure: Timing of cholecystectomy
timeFrame: hours
measure: Timing of MRCP
timeFrame: hours
measure: Complications
timeFrame: 30 days
measure: Length of hospital stay
timeFrame: days
Other outcomes:
Locations:
city: Jyväskylä
country: Finland
facility: Central Finland Central Hospital
Study officials:
affiliation: Central Finland Central Hospital
name: Anne Mattila, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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