Clinical Trials Directory

Trials / Completed

CompletedNCT04059601

Magnetic Resonance Cholangiography and Intraoperative Cholangiography in Acute Cholecystitis

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

Status
Completed
Phase
Study type
Observational
Enrollment
180 (actual)
Sponsor
Jyväskylä Central Hospital · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTMagnetic resonance cholangiographypreoperative MRCP in acute cholecystitis before cholecystectomy
DIAGNOSTIC_TESTIntraoperative cholangiographyIntraoperative cholangiography in acute cholecystitis during cholecystectomy

Timeline

Start date
2019-01-01
Primary completion
2019-12-31
Completion
2020-12-31
First posted
2019-08-16
Last updated
2021-03-18

Locations

1 site across 1 country: Finland

Source: ClinicalTrials.gov record NCT04059601. Inclusion in this directory is not an endorsement.

Magnetic Resonance Cholangiography and Intraoperative Cholangiography in Acute Cholecystitis (NCT04059601) · Clinical Trials Directory