Magnetic Resonance Cholangiography and Intraoperative Cholangiography in Acute Cholecystitis

Acute Cholecystitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04059601
• Other study ID #: Imaging in acute cholecystitis
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2021
• Source: Jyväskylä Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Clinically and radiologically confirmed acute cholecystitis

Exclusion Criteria:

• Contraindication for MRCP

• Patients refuses MRCP

Related Conditions & MeSH terms

• Acute Cholecystitis
• Cholecystitis
• Cholecystitis, Acute

Intervention

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

Locations

Country	Name	City	State
Finland	Central Finland Central Hospital	Jyväskylä

Sponsors (1)

Lead Sponsor	Collaborator
Jyväskylä Central Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (7)

Blohm M, Österberg 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 Gastrointes — View Citation

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. Review. — View Citation

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. Epub 2016 O — View Citation

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. — View Citation

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. — View Citation

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/s10140-012-10 — View Citation

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 (Oxf — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRCP quality	Comparing radiology interobserver findings of preoperative MRCP	Hospital admission
Secondary	Success of intraoperative cholangiography	number of performed intraoperative cholangiographies	1 year
Secondary	preoperative MRCP	proportion of patients with bile duct stones in MRCP	1 year
Secondary	Intraoperative cholangiography	Number of patients with bile duct stones in intraoperative cholangiography	During operation
Secondary	Conversion	proportion of patients with converted laparoscopic cholecystectomy	During operation
Secondary	Timing of cholecystectomy	Time gap between onset of symptoms and cholecystectomy	hours
Secondary	Timing of MRCP	Time gap between hospital admission and MRCP	hours
Secondary	Complications	Surgical complications	30 days
Secondary	Length of hospital stay	number of days patients spent in hospital	days