Acute CholecystitisELC-PUMCHNCT06552949
A Prospective Cohort of Emergent Laparoscopic Cholecystectomy in PUMCH
An observational study of Acute Cholecystitis, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
A prospective cohort study comparing the surgical outcome of patients who underwent emergent laparoscopic cholecystectomy guided by indocyanine green cholangiography (ELC-ICGC) versus conventional laparoscopic operation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Cholecystitis
- What is being tested?
- Emergent laparoscopic cholecystectomy guided by ICG cholangiography (ELC-ICGC)
- Type of treatment
- Surgery or procedure
- How many people
- 750 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 1 Jun 2024
- 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
- Child, Adult, Older adult
Study population: All of the hospitalized patients who underwent ELC by the emergent surgery team from August 1st 2020 to 1st Feburary 2024 in the Department of Emergency in Peking Union Medical College Hospital
Who may be able to join
- Patients underwent ELC performed by the emergent surgeon team Approval to participate
Who cannot join
- Patients with incomplete medical records. Patients have other emergent conditions which warrant other emergent operations or major treatment simultaneously besides ELC.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100730
About this study
Official title: Prospective Cohort Study on Emergent Laparoscopic Cholecystectomy Guided by Indocyanine Green (ICG) Fluorescence Versus Conventional Laparoscopic Operation
A prospective cohort study comparing the surgical outcome of patients who underwent emergent laparoscopic cholecystectomy guided by indocyanine green cholangiography (ELC-ICGC) versus conventional laparoscopic operation. The patients were recruited in the Peking Union Medical Colleg Hospital emergency department from 1st August 2020 to 1st Feburary 2024. A database was prospectively established to collect related data. The surgical outcomes of ELC-ICGC and conventional ElC will be compared.
Read the detailed description
Acute calculous cholecystitis, typically occurs in patients with gallstones, accounts for 90 to 95% of acute cholecystitis. Emergent laparoscopic cholecystectomy (ELC) is the major treatment option. Traditionally, the time frame for ELC is generally considered to be within 72 hours from the onset of symptoms. However, with the development of surgical techniques, nowadays, ELC is also considered for patients with symptoms onset within 10 days and hospital stays within 7 days. The determination of the time frame for ELC in acute cholecystitis is primarily based on the risk of complications occurring. Comparing to delayed laparoscopic cholecystectomy (DLC), ELC has advantages in post-operative complications in patients with symptoms onset within 72 hours. Post-operative complications for both DLC and ELC include bile leaks, intestinal obstruction, ascites, intraperitoneal hemorrhage, would bleeding and hematoma, wound infection and calculus remaining. Most of them associate with intraoperative procedures. Emergent laparoscopic cholecystectomy guided by indocyanine green (ICG) cholangiography (ELC-ICGC), comparing to conventional LC, potentially can help the surgeons to identify bile tracts and therefore may reduce the complications.
From August 1st 2020, the AC patients undergoing LC in PUMCH were prospecteively registered and a database was established to collect related data.
Till 1st Feburary 2024, about 750 cases of ELC were performed. The surgeons chose to perform either conventional ELC or ELC-ICGC based on their discretion. The patients were followed up within one month after discharge in out patient clinic or telephone interview. We plan to analyze the data from the prospectively established- database.
The surgical outcomes are evaluated by both intraoperative events and postoperative events. Intraoperative events contain the following items: (1) incidence of intraoperative accidental bile tract injury, (2) intraoperative bleeding (volume), (3) operation time. Postoperative events contain the following items: (1) incidence of complications staging 2 and above according to Clavien Dindo Grade during hospital stay, (2) duration of postoperative hospital stay. The economic effectiveness is evaluated by cost of hospital stay.
The surgical outcomes of these two procedures will be compared.
- Conditions
- Acute Cholecystitis
- Being tested
- Emergent laparoscopic cholecystectomy guided by ICG cholangiography (ELC-ICGC)
- Keywords
- Emergent laparscopic cholecystectomy, indocyanine green fluorescence, surgical outcome, economic effectiveness, acute cholecystitis
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergent laparoscopic cholecystectomy guided by ICG cholangiography (ELC-ICGC)Procedure or surgery
Emergent conventional laparoscopic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patient undergoing emergent laparoscpic cholecystectomy guided by indocyanine green cholangiography (ELC-ICGC) Receives: Procedure: Emergent laparoscopic cholecystectomy guided by ICG cholangiography (ELC-ICGC) | |
| Control group | Patient undergoing emergent conventional laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of intraoperative accidental bile tract injury
The primary outcome is incidence of intraoperative accidental injury involving the bile tract in emergent laparscopic cholecystectomy (ELC) guided by ICG fluorescence. The injury manifests as biliary obstruction, biliary leak, or biliary stricture. Medical records will be reviewed to identify an intraoperative bile tract injury event. Incidence of intraoperative accidental bile tract injury will be collected and comparison between study group (ELC guided by ICG fluorescence) and control group (conventional ELC) will be made
Measured: within 1 month
incidence of complications
incidence of complications staging 2 and above according to Clavien Dindo Grade during hospital stay
Measured: within 1 month
Secondary outcomes (4)
intraoperative bleeding (volume)
Volume of intraoperative bleeding during the operation
Measured: Intraoperative
duration of postoperative hospital stay
Days of postoperative hospital stay
Measured: within 1 month
total medical expense
Cost during hospital stay
Measured: within 1 month
operation time
from cutting the incison to ending the suturing of the incision
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start1 Aug 2020
- Primary completion1 Feb 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute CholecystitisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiaofei Liu, Peking Union Medical College Hospital
- Investigators
- Qiaofei Liu, M.D, Study chair, Department of General Surgery, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552949
- Sponsor's protocol ID
- K6454-K24C2458
- Acronym
- ELC-PUMCH
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study on Emergent Laparoscopic Cholecystectomy Guided by Indocyanine Green (ICG) Fluorescence Versus Conventional Laparoscopic Operation
- ClinicalTrials.gov ID
- NCT06552949
- Acronym / sponsor ID
- ELC-PUMCH / K6454-K24C2458
- Conditions
- Acute Cholecystitis
- Keywords
- Emergent laparscopic cholecystectomy, indocyanine green fluorescence, surgical outcome, economic effectiveness, acute cholecystitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 14 Aug 2024 (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.
A prospective cohort study comparing the surgical outcome of patients who underwent emergent laparoscopic cholecystectomy guided by indocyanine green cholangiography (ELC-ICGC) versus conventional laparoscopic operation. The patients were recruited in the Peking Union Medical Colleg Hospital emergency department from 1st August 2020 to 1st Feburary 2024. A database was prospectively established to collect related data. The surgical outcomes of ELC-ICGC and conventional ElC will be compared.
Detailed description
Acute calculous cholecystitis, typically occurs in patients with gallstones, accounts for 90 to 95% of acute cholecystitis. Emergent laparoscopic cholecystectomy (ELC) is the major treatment option. Traditionally, the time frame for ELC is generally considered to be within 72 hours from the onset of symptoms. However, with the development of surgical techniques, nowadays, ELC is also considered for patients with symptoms onset within 10 days and hospital stays within 7 days. The determination of the time frame for ELC in acute cholecystitis is primarily based on the risk of complications occurring. Comparing to delayed laparoscopic cholecystectomy (DLC), ELC has advantages in post-operative complications in patients with symptoms onset within 72 hours. Post-operative complications for both DLC and ELC include bile leaks, intestinal obstruction, ascites, intraperitoneal hemorrhage, would bleeding and hematoma, wound infection and calculus remaining. Most of them associate with intraoperative procedures. Emergent laparoscopic cholecystectomy guided by indocyanine green (ICG) cholangiography (ELC-ICGC), comparing to conventional LC, potentially can help the surgeons to identify bile tracts and therefore may reduce the complications.
From August 1st 2020, the AC patients undergoing LC in PUMCH were prospecteively registered and a database was established to collect related data.
Till 1st Feburary 2024, about 750 cases of ELC were performed. The surgeons chose to perform either conventional ELC or ELC-ICGC based on their discretion. The patients were followed up within one month after discharge in out patient clinic or telephone interview. We plan to analyze the data from the prospectively established- database.
The surgical outcomes are evaluated by both intraoperative events and postoperative events. Intraoperative events contain the following items: (1) incidence of intraoperative accidental bile tract injury, (2) intraoperative bleeding (volume), (3) operation time. Postoperative events contain the following items: (1) incidence of complications staging 2 and above according to Clavien Dindo Grade during hospital stay, (2) duration of postoperative hospital stay. The economic effectiveness is evaluated by cost of hospital stay.
The surgical outcomes of these two procedures will be compared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Procedure: Emergent laparoscopic cholecystectomy guided by ICG cholangiography (ELC-ICGC)Patient undergoing emergent laparoscpic cholecystectomy guided by indocyanine green cholangiography (ELC-ICGC) |
| Control group | – | –Patient undergoing emergent conventional laparoscopic cholecystectomy |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All of the hospitalized patients who underwent ELC by the emergent surgery team from August 1st 2020 to 1st Feburary 2024 in the Department of Emergency in Peking Union Medical College Hospital
Key inclusion criteria (1 listed)
- Patients underwent ELC performed by the emergent surgeon team Approval to participate
Key exclusion criteria (1 listed)
- Patients with incomplete medical records. Patients have other emergent conditions which warrant other emergent operations or major treatment simultaneously besides ELC.
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 |
|---|---|---|
| Emergent laparoscopic cholecystectomy guided by ICG cholangiography (ELC-ICGC)Emergent conventional laparoscopic cholecystectomy | Procedure or surgery | Study group |
Primary outcome
incidence of intraoperative accidental bile tract injury
Time frame: within 1 month
The primary outcome is incidence of intraoperative accidental injury involving the bile tract in emergent laparscopic cholecystectomy (ELC) guided by ICG fluorescence. The injury manifests as biliary obstruction, biliary leak, or biliary stricture. Medical records will be reviewed to identify an intraoperative bile tract injury event. Incidence of intraoperative accidental bile tract injury will be collected and comparison between study group (ELC guided by ICG fluorescence) and control group (conventional ELC) will be made
incidence of complications
Time frame: within 1 month
incidence of complications staging 2 and above according to Clavien Dindo Grade during hospital stay
4 secondary outcomes
intraoperative bleeding (volume)
Time frame: Intraoperative
duration of postoperative hospital stay
Time frame: within 1 month
total medical expense
Time frame: within 1 month
operation time
Time frame: Intraoperative
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 14 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Acute Cholecystitis
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.
Qiaofei Liu, M.D study chair
Department of General Surgery, Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Cholecystitis, run by Peking Union Medical College Hospital at 1 site in China.
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 1 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 14 Aug 2024. 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 China. 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?
incidence of intraoperative accidental bile tract injury (time frame: within 1 month). The study lists 2 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 14 Aug 2024.