Magnetic Resonance Cholangiography and Intraoperative Cholangiography in Acute Cholecystitis

Sponsor
Jyväskylä Central Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04059601
Collaborator
(none)
180
1
24
7.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Magnetic resonance cholangiography
  • Diagnostic Test: Intraoperative cholangiography

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 Design

Study Type:
Observational
Actual Enrollment :
180 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Study on Impact of Preoperative Magnetic Resonance Cholangiopancreatography (MRCP) and Intraoperative Cholangiography (IOC) in Surgical Treatment of Acute Cholecystitis
Actual Study Start Date :
Jan 1, 2019
Actual Primary Completion Date :
Dec 31, 2019
Actual Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Patients with acute cholecystitis

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.

Diagnostic Test: Magnetic resonance cholangiography
preoperative MRCP in acute cholecystitis before cholecystectomy

Diagnostic Test: Intraoperative cholangiography
Intraoperative cholangiography in acute cholecystitis during cholecystectomy

Outcome Measures

Primary Outcome Measures

  1. MRCP quality [Hospital admission]

    Comparing radiology interobserver findings of preoperative MRCP

Secondary Outcome Measures

  1. Success of intraoperative cholangiography [1 year]

    number of performed intraoperative cholangiographies

  2. preoperative MRCP [1 year]

    proportion of patients with bile duct stones in MRCP

  3. Intraoperative cholangiography [During operation]

    Number of patients with bile duct stones in intraoperative cholangiography

  4. Conversion [During operation]

    proportion of patients with converted laparoscopic cholecystectomy

  5. Timing of cholecystectomy [hours]

    Time gap between onset of symptoms and cholecystectomy

  6. Timing of MRCP [hours]

    Time gap between hospital admission and MRCP

  7. Complications [30 days]

    Surgical complications

  8. Length of hospital stay [days]

    number of days patients spent in hospital

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

• Clinically and radiologically confirmed acute cholecystitis

Exclusion Criteria:
  • Contraindication for MRCP

  • Patients refuses MRCP

Contacts and Locations

Locations

Site City State Country Postal Code
1 Central Finland Central Hospital Jyväskylä Finland 40620

Sponsors and Collaborators

  • Jyväskylä Central Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Olli Helminen, MD, PhD, Jyväskylä Central Hospital
ClinicalTrials.gov Identifier:
NCT04059601
Other Study ID Numbers:
  • Imaging in acute cholecystitis
First Posted:
Aug 16, 2019
Last Update Posted:
Mar 18, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Olli Helminen, MD, PhD, Jyväskylä Central Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 18, 2021