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