Cholecystitis, AcuteCholeRiskScoreNCT04511910
How to Predict Postoperative Complications After Early Laparoscopic Cholecystectomy for Acute Cholecystitis: the Chole-Risk Score
An observational study of Cholecystitis, Acute, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 11 sites in Spain.
Trial summary
Acute calculous cholecystitis (ACC) is the most common complication of gallstone disease, and laparoscopic cholecystectomy is the gold standard treatment. Several prospective studies have demonstrated that same-admission, early LC (ELC), for ACC is safe when compared with delayed LC (DLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystitis, Acute
- What is being tested?
- Early Laparoscopic Cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 1,868 participants
- Where
- 11 sitesSpain
- Study dates
- 1 Jan 2013to 30 Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CLP surgery patients between January 2013 and December 2018. The diagnosis of acute cholecystitis will be established according to the Tokio Guidelines: * Local signs (pain in right hypochondrium / Murphy's sign). * Systemic (fever / elevated C-reactive protein / leukocytosis) * Ultrasound findings (gallbladder distension, wall thickening, pericolectic fluid or radiological Murphy's sign, associated with gallstones). In all patients, treatment with antibiotics will be carried out according to each hospital's protocols in terms of type and duration.
Who may be able to join
- Patients aged 18 years or older diagnosed with Acute calculous cholecystitis.
- Consecutive patients undergoing early laparoscopic cholecystectomy between January 2013 and December 2018 during admission for the acute episode.
- Minimum 30-day post-operative follow-up.
- ASA ≤ 3.
Who cannot join
- Presence of another concomitant pathology of the bile duct (choledocholithiasis, cholangitis, pancreatitis, biliary peritonitis).
- Aetiology other than cholelithiasis (amythiasis, malignancy).
- Patients with severe sepsis, immunosuppression and pregnancy.
- Additional abdominal surgical procedure.
- ASA 4.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Spain11 sites
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid
Hospital Universitario German Trias I Pujol
Badalona, Barcelona
Hospital Universitario Cruces
Bilbao, Vizcaya
Hospital de Cabueñes
Gijón, Principality of Asturias
Hospital Universitario de la Princesa
Madrid, 28006
Hospital General Universitario Gregorio Marañón
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario Ramón y Cajal
Madrid
Complejo Asistencial Universitario Salamanca
Salamanca
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria
Hospital Universitario Virgen del Rocío
Seville
About this study
Acute calculous cholecystitis (ACC) is the most common complication of gallstone disease, and laparoscopic cholecystectomy is the gold standard treatment. Several prospective studies have demonstrated that same-admission, early LC (ELC), for ACC is safe when compared with delayed LC (DLC). However, there is still controversy on the indication of ELC in high risk patients with important comorbidities, in cases of severe inflammation of the gallbladder and in patients with ACC and suspicious of a choledocholithiasis. The advantages of ELC in high risk patients with severe comorbidities have been recently questioned, with Tokyo Guidelines 2018 (TG18) proposing an initial conservative management of this cases, assessing the benefit of ELC according to specified criteria. However, the recent CHOCOLATE trial, demonstrated the advantages of ELC over an initial conservative management. Performing an ELC for ACC can be a straightforward procedure for an on-call general surgeon or a very challenging procedure even for experienced hepatopancreaticobiliary (HPB) laparoscopic surgeon, depending on disease features, surgeons experience, centres volumes and resources available. Deciding whether the ELC should be performed by the on-call team or by HPB surgical team, or whether the operation should be delayed are still matter of debate in daily practice.
Several preoperative scores assessing the risk of difficult cholecystectomy have been proposed, but they were mainly focused on elective procedures and on risk of conversion to open cholecystectomy or other intraoperative complications. They did not asses the risk of post-operative complications in a subgroup of patients, for whom, indication to ELC by the on-call general surgeon is still questionable according to the more recent guidelines.
- Conditions
- Cholecystitis, Acute
- Being tested
- Early Laparoscopic Cholecystectomy
- Keywords
- Acute cholecystitis, Cholecystectomy, Gallbladder
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Laparoscopic CholecystectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Early surgery Group 1 | The surgery is performed within the first 3 days Receives: Procedure: Early Laparoscopic Cholecystectomy | |
| Early surgery Group 2 | Surgery is performed between the fourth and seventh day Receives: Procedure: Early Laparoscopic Cholecystectomy | |
| Early surgery Group 3 | Surgery is performed more than 7 days from the onset of symptoms Receives: Procedure: Early Laparoscopic Cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased post-operative complications
Patients who only developed Clavien-Dindo I-II complications were assigned to group 1 (G1), whereas groups 2 (G2) included patients with post-operative complications ≥ IIIa. Patients with post-operative LOS greater than 10 days and who required readmissions within 30 days from the discharge were also assigned to G2.
Measured: For at least 30 postoperative days
Number of Participants with Postoperative hemorrhagia
Postoperative hemorrhagia
Measured: For at least 30 postoperative days
Number of Participants with Biliary fistula
Biliary fistula
Measured: For at least 30 postoperative days
Number of Participants with Jaundice
Jaundice
Measured: For at least 30 postoperative days
Number of Participants with Cardiac insufficiency
Cardiac insufficiency
Measured: For at least 30 postoperative days
Number of Participants with Heart infarction
Heart infarction
Measured: For at least 30 postoperative days
Number of Participants with Respiratory insufficiency
Respiratory insufficiency
Measured: For at least 30 postoperative days
Number of Participants with Pulmonary thromboembolism
Pulmonary thromboembolism
Measured: For at least 30 postoperative days
Number of Participants with Kidney failure or dialysis
Kidney failure or dialysis
Measured: For at least 30 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start1 Jan 2013
- Primary completion31 Jul 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystitis, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Retrospective
- Enrolment
- 1,868 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Sponsor type
- University, hospital or other
- Collaborators
- Marcello Di Martino
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511910
- Sponsor's protocol ID
- CholeRisk Score
- Acronym
- CholeRiskScore
- Status last verified
- Dec 2020
- First submitted
- 11 Aug 2020
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How to Predict Postoperative Complications After Early Laparoscopic Cholecystectomy for Acute Cholecystitis: the Chole-Risk Score
- ClinicalTrials.gov ID
- NCT04511910
- Acronym / sponsor ID
- CholeRiskScore / CholeRisk Score
- Conditions
- Cholecystitis, Acute
- Keywords
- Acute cholecystitis, Cholecystectomy, Gallbladder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,868 participants (actual)
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaUniversity, hospital or other
- Collaborators
- Marcello Di Martino
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute calculous cholecystitis (ACC) is the most common complication of gallstone disease, and laparoscopic cholecystectomy is the gold standard treatment. Several prospective studies have demonstrated that same-admission, early LC (ELC), for ACC is safe when compared with delayed LC (DLC). However, there is still controversy on the indication of ELC in high risk patients with important comorbidities, in cases of severe inflammation of the gallbladder and in patients with ACC and suspicious of a choledocholithiasis. The advantages of ELC in high risk patients with severe comorbidities have been recently questioned, with Tokyo Guidelines 2018 (TG18) proposing an initial conservative management of this cases, assessing the benefit of ELC according to specified criteria. However, the recent CHOCOLATE trial, demonstrated the advantages of ELC over an initial conservative management. Performing an ELC for ACC can be a straightforward procedure for an on-call general surgeon or a very challenging procedure even for experienced hepatopancreaticobiliary (HPB) laparoscopic surgeon, depending on disease features, surgeons experience, centres volumes and resources available. Deciding whether the ELC should be performed by the on-call team or by HPB surgical team, or whether the operation should be delayed are still matter of debate in daily practice.
Several preoperative scores assessing the risk of difficult cholecystectomy have been proposed, but they were mainly focused on elective procedures and on risk of conversion to open cholecystectomy or other intraoperative complications. They did not asses the risk of post-operative complications in a subgroup of patients, for whom, indication to ELC by the on-call general surgeon is still questionable according to the more recent guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early surgery Group 1 | – | Procedure: Early Laparoscopic CholecystectomyThe surgery is performed within the first 3 days |
| Early surgery Group 2 | – | Procedure: Early Laparoscopic CholecystectomySurgery is performed between the fourth and seventh day |
| Early surgery Group 3 | – | Procedure: Early Laparoscopic CholecystectomySurgery is performed more than 7 days from the onset of symptoms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CLP surgery patients between January 2013 and December 2018. The diagnosis of acute cholecystitis will be established according to the Tokio Guidelines: * Local signs (pain in right hypochondrium / Murphy's sign). * Systemic (fever / elevated C-reactive protein / leukocytosis) * Ultrasound findings (gallbladder distension, wall thickening, pericolectic fluid or radiological Murphy's sign, associated with gallstones). In all patients, treatment with antibiotics will be carried out according to each hospital's protocols in terms of type and duration.
Key inclusion criteria (4 listed)
- Patients aged 18 years or older diagnosed with Acute calculous cholecystitis.
- Consecutive patients undergoing early laparoscopic cholecystectomy between January 2013 and December 2018 during admission for the acute episode.
- Minimum 30-day post-operative follow-up.
- ASA ≤ 3.
Key exclusion criteria (5 listed)
- Presence of another concomitant pathology of the bile duct (choledocholithiasis, cholangitis, pancreatitis, biliary peritonitis).
- Aetiology other than cholelithiasis (amythiasis, malignancy).
- Patients with severe sepsis, immunosuppression and pregnancy.
- Additional abdominal surgical procedure.
- ASA 4.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Laparoscopic Cholecystectomy | Procedure or surgery | Early surgery Group 1, Early surgery Group 2, Early surgery Group 3 |
Primary outcome
Increased post-operative complications
Time frame: For at least 30 postoperative days
Patients who only developed Clavien-Dindo I-II complications were assigned to group 1 (G1), whereas groups 2 (G2) included patients with post-operative complications ≥ IIIa. Patients with post-operative LOS greater than 10 days and who required readmissions within 30 days from the discharge were also assigned to G2.
Number of Participants with Postoperative hemorrhagia
Time frame: For at least 30 postoperative days
Postoperative hemorrhagia
Number of Participants with Biliary fistula
Time frame: For at least 30 postoperative days
Biliary fistula
Number of Participants with Jaundice
Time frame: For at least 30 postoperative days
Jaundice
Number of Participants with Cardiac insufficiency
Time frame: For at least 30 postoperative days
Cardiac insufficiency
Number of Participants with Heart infarction
Time frame: For at least 30 postoperative days
Heart infarction
Number of Participants with Respiratory insufficiency
Time frame: For at least 30 postoperative days
Respiratory insufficiency
Number of Participants with Pulmonary thromboembolism
Time frame: For at least 30 postoperative days
Pulmonary thromboembolism
Number of Participants with Kidney failure or dialysis
Time frame: For at least 30 postoperative days
Kidney failure or dialysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Cholecystitis, Acute
Not yet recruitingObservational study
SnapChole: An International, Time-Bound Prospective Platform Study of Management Strategies and Outcomes in Acute Calculous Cholecystitis
Cholecystitis, Acute
Not yet recruiting
Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis
Cholecystitis, Acute
RecruitingObservational study
Influence of Gut Microbiome in Gallstone Disease
Gall Stone, Gall Stones, Common Bile Duct
Recruiting
Repeat Biliary Point of Care Ultrasound for Detecting Early Acute Cholecystitis
Cholecystitis, Acute, Biliary Diseases
Not yet recruiting
Implementation of RICA (ERAS) Guidelines in Grade II Acute Cholecystitis Undergoing Early Laparoscopic Cholecystectomy
Cholecystitis, Acute, Cholecystectomy, Laparoscopic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholecystitis, Acute, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 11 sites in Spain.
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 4 inclusion and 5 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 29 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 11 sites in Spain. 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?
Increased post-operative complications (time frame: For at least 30 postoperative days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2021.