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Acute CholecystitisNCT04059601

Magnetic Resonance Cholangiography and Intraoperative Cholangiography in Acute Cholecystitis

An observational study of Acute Cholecystitis, run by Jyväskylä Central Hospital at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Acute Cholecystitis
What is being tested?
Magnetic resonance cholangiography and Intraoperative cholangiography
How many people
180 participants
Where
1 siteFinland
Study dates
1 Jan 2019to 31 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • Clinically and radiologically confirmed acute cholecystitis

Who cannot join

  • Contraindication for MRCP
  • Patients refuses MRCP

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • Central Finland Central Hospital

    Jyväskylä, 40620

Other trials in Finland

About this study

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

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.

Read the 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.

Being tested
Magnetic resonance cholangiography, Intraoperative cholangiography
Keywords
common bile duct stones, cholecystectomy
Medical subject headings
Cholecystitis, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnetic resonance cholangiographyDiagnostic test

    preoperative MRCP in acute cholecystitis before cholecystectomy

  • Intraoperative cholangiographyDiagnostic test

    Intraoperative cholangiography in acute cholecystitis during cholecystectomy

Study groups in NCT04059601
Study groupRoleWhat they receive
Patients with acute cholecystitisAll patients with acute cholecystitis are included in the study cohort during year 2019. MRCP and IOC will be performed to all patients whenever feasible.
Receives: Diagnostic Test: Magnetic resonance cholangiography; Diagnostic Test: Intraoperative cholangiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MRCP quality

    Comparing radiology interobserver findings of preoperative MRCP

    Measured: Hospital admission

Secondary outcomes (8)

  1. Success of intraoperative cholangiography

    number of performed intraoperative cholangiographies

    Measured: 1 year

  2. preoperative MRCP

    proportion of patients with bile duct stones in MRCP

    Measured: 1 year

  3. Intraoperative cholangiography

    Number of patients with bile duct stones in intraoperative cholangiography

    Measured: During operation

  4. Conversion

    proportion of patients with converted laparoscopic cholecystectomy

    Measured: During operation

  5. Timing of cholecystectomy

    Time gap between onset of symptoms and cholecystectomy

    Measured: hours

  6. Timing of MRCP

    Time gap between hospital admission and MRCP

    Measured: hours

  7. Complications

    Surgical complications

    Measured: 30 days

  8. Length of hospital stay

    number of days patients spent in hospital

    Measured: days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2019
  2. Study start1 Jan 2019
  3. Primary completion31 Dec 2019
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04059601
Sponsor's protocol ID
Imaging in acute cholecystitis
Status last verified
Mar 2021
First submitted
3 Jan 2019
Last updated
18 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 25422672

  • 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.

    PubMed 27741006

  • 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.

    PubMed 27649704

  • 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.

    PubMed 21762294

  • 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.

    PubMed 27847796

  • 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.

    PubMed 22447440

  • 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.

    PubMed 14530225

  • 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.

    PubMed 37578567

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Cholecystitis, run by Jyväskylä Central Hospital at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MRCP quality (time frame: Hospital admission). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04059601, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.

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