Magnetic Resonance Cholangiography and Intraoperative Cholangiography in Acute Cholecystitis

NCT04059601 | Completed

• 1 other identifier: Imaging in acute cholecystitis
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Cholecystitis

Keywords

common bile duct stones; cholecystectomy

Outcome Measures

Primary Outcomes (1)

• MRCP quality

  Comparing radiology interobserver findings of preoperative MRCP

  Hospital admission

Secondary Outcomes (8)

• Success of intraoperative cholangiography

  1 year

• preoperative MRCP

  1 year

• Intraoperative cholangiography

  During operation

• Conversion

  During operation

• Timing of cholecystectomy

  hours

Study Arms (1)

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; Diagnostic Test: Intraoperative cholangiography

Interventions

Magnetic resonance cholangiography DIAGNOSTIC_TEST

preoperative MRCP in acute cholecystitis before cholecystectomy

Patients with acute cholecystitis

Intraoperative cholangiography DIAGNOSTIC_TEST

Intraoperative cholangiography in acute cholecystitis during cholecystectomy

Patients with acute cholecystitis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients in Central Finland Central Hospital district hospitalized and operated due to acute cholecystitis.

You may qualify if:

• Clinically and radiologically confirmed acute cholecystitis

You may not qualify if:

• Contraindication for MRCP
• Patients refuses MRCP

Sponsors & Collaborators

• Jyväskylä Central Hospital: lead

Study Sites (1)

Central Finland Central Hospital

Jyväskylä, 40620, Finland

Location

Related Publications (8)

• Campanile FC, Pisano M, Coccolini F, Catena F, Agresta F, Ansaloni L. Acute cholecystitis: WSES position statement. World J Emerg Surg. 2014 Nov 18;9(1):58. doi: 10.1186/1749-7922-9-58. eCollection 2014.

  PMID: 25422672 RESULT

• Roulin D, Saadi A, Di Mare L, Demartines N, Halkic N. Early Versus Delayed Cholecystectomy for Acute Cholecystitis, Are the 72 hours Still the Rule?: A Randomized Trial. Ann Surg. 2016 Nov;264(5):717-722. doi: 10.1097/SLA.0000000000001886.

  PMID: 27741006 RESULT

• Blohm M, Osterberg J, Sandblom G, Lundell L, Hedberg M, Enochsson L. The Sooner, the Better? The Importance of Optimal Timing of Cholecystectomy in Acute Cholecystitis: Data from the National Swedish Registry for Gallstone Surgery, GallRiks. J Gastrointest Surg. 2017 Jan;21(1):33-40. doi: 10.1007/s11605-016-3223-y. Epub 2016 Sep 20.

  PMID: 27649704 RESULT

• Videhult P, Sandblom G, Rudberg C, Rasmussen IC. Are liver function tests, pancreatitis and cholecystitis predictors of common bile duct stones? Results of a prospective, population-based, cohort study of 1171 patients undergoing cholecystectomy. HPB (Oxford). 2011 Aug;13(8):519-27. doi: 10.1111/j.1477-2574.2011.00317.x. Epub 2011 May 11.

  PMID: 21762294 RESULT

• Lee DH, Ahn YJ, Lee HW, Chung JK, Jung IM. Prevalence and characteristics of clinically significant retained common bile duct stones after laparoscopic cholecystectomy for symptomatic cholelithiasis. Ann Surg Treat Res. 2016 Nov;91(5):239-246. doi: 10.4174/astr.2016.91.5.239. Epub 2016 Oct 31.

  PMID: 27847796 RESULT

• Tonolini M, Ravelli A, Villa C, Bianco R. Urgent MRI with MR cholangiopancreatography (MRCP) of acute cholecystitis and related complications: diagnostic role and spectrum of imaging findings. Emerg Radiol. 2012 Aug;19(4):341-8. doi: 10.1007/s10140-012-1038-z. Epub 2012 Mar 25.

  PMID: 22447440 RESULT

• Romagnuolo J, Bardou M, Rahme E, Joseph L, Reinhold C, Barkun AN. Magnetic resonance cholangiopancreatography: a meta-analysis of test performance in suspected biliary disease. Ann Intern Med. 2003 Oct 7;139(7):547-57. doi: 10.7326/0003-4819-139-7-200310070-00006.

  PMID: 14530225 RESULT

• Mattila A, Helminen O, Pynnonen E, Sironen A, Elomaa E, Nevalainen M. Preoperative MRCP Can Rule Out Choledocholithiasis in Acute Cholecystitis with a High Negative Predictive Value: Prospective Cohort Study with Intraoperative Cholangiography. J Gastrointest Surg. 2023 Nov;27(11):2396-2402. doi: 10.1007/s11605-023-05790-x. Epub 2023 Aug 14.

  PMID: 37578567 DERIVED

MeSH Terms

Conditions

Cholecystitis, Acute

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Anne Mattila, MD,PhD

  Central Finland Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: August 16, 2019
• Study Start: January 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: March 18, 2021

Record last verified: 2021-03

Locations

FI (1)