Acute Cholestatic HepatitisELG-ICGCNCT06549881
Emergent Laparoscopic Cholecystectomy With ICG Cholangiography
An observational study of Acute Cholestatic Hepatitis, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
A consecutive case series report to share our experience in surgical outcome of patients who underwent emergency laparoscopic cholecystectomy guided by indocyanine green (ICG) fluorescence. The patients were recruited in PUMCH emergency department from 2023 to 2024. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Cholestatic Hepatitis
- What is being tested?
- emergency laparoscopic cholecystectomy guided by indocyanine green (ICG) fluorescence
- Type of treatment
- Surgery or procedure
- How many people
- 97 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 1 Aug 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with acute cholecystitis warrant emergent laparscopic cholecystectomy.
Who may be able to join
- All of the hospitalized patients of underwent emergent laparscopic cholecystectomy guided by ICG fluorescence by the emergent surgeon team from 1st August 2023 to 1st Feburary 2024 in the department of Emergency in Peking Union Medical College Hospital
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: Emergency Laparoscopic Cholecystectomy Guided by Indocyanine Green (ICG) Fluorescence: a Single Center Experience
A consecutive case series report to share our experience in surgical outcome of patients who underwent emergency laparoscopic cholecystectomy guided by indocyanine green (ICG) fluorescence. The patients were recruited in PUMCH emergency department from 2023 to 2024.
Read the detailed description
Acute calculous cholecystitis, typically occurs in patients with gallstones, accounts for 90 to 95% of acute cholecystitis. Emergent laparscopic 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 laparscopic 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. Laparoscopic cholecystectomy guided by indocyanine green (ICG) fluorescence, comparing to conventional laparscopic procedures, can help the surgeons to identify bile tracts and therefore may reduce the complications. Therefore, we conduct this case series report to share our single center experience of surgical outcomes and economic effectiveness of laparoscopic cholecystectomy guided by ICG.
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.
- Conditions
- Acute Cholestatic Hepatitis
- Being tested
- emergency laparoscopic cholecystectomy guided by indocyanine green (ICG) fluorescence
- 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.
emergency laparoscopic cholecystectomy guided by indocyanine green (ICG) fluorescenceProcedure or surgery
emergency laparoscopic cholecystectomy guided by indocyanine green (ICG) fluorescence
| Study group | Role | What they receive |
|---|---|---|
| ICG fluorescence guided group | Patients with acute cholecystitis underwent emergent laparscopic cholecystectomy guided by indocyanine green (ICG) fluorescence. Receives: Procedure: emergency laparoscopic cholecystectomy guided by indocyanine green (ICG) fluorescence |
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 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.
Measured: within 1 month after after discharge
incidence of postoperative complications
incidence of complications staging 2 and above according to Clavien Dindo Grade during hospital stay
Measured: within 1 month after discharge
Secondary outcomes (1)
duration of postoperative hospital stay
Days of postoperative hospital stay
Measured: within 1 month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start1 Aug 2023
- Primary completion1 Feb 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Cholestatic HepatitisStudies 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
- 97 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, Principal investigator, Department of General Surgery, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549881
- Sponsor's protocol ID
- K5730-K24C2175
- Acronym
- ELG-ICGC
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2024
- Last updated
- 12 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 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Laparoscopic Cholecystectomy Guided by Indocyanine Green (ICG) Fluorescence: a Single Center Experience
- ClinicalTrials.gov ID
- NCT06549881
- Acronym / sponsor ID
- ELG-ICGC / K5730-K24C2175
- Conditions
- Acute Cholestatic Hepatitis
- Keywords
- Emergent laparscopic cholecystectomy, indocyanine green fluorescence, surgical outcome, economic effectiveness, acute cholecystitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 12 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 consecutive case series report to share our experience in surgical outcome of patients who underwent emergency laparoscopic cholecystectomy guided by indocyanine green (ICG) fluorescence. The patients were recruited in PUMCH emergency department from 2023 to 2024.
Detailed description
Acute calculous cholecystitis, typically occurs in patients with gallstones, accounts for 90 to 95% of acute cholecystitis. Emergent laparscopic 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 laparscopic 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. Laparoscopic cholecystectomy guided by indocyanine green (ICG) fluorescence, comparing to conventional laparscopic procedures, can help the surgeons to identify bile tracts and therefore may reduce the complications. Therefore, we conduct this case series report to share our single center experience of surgical outcomes and economic effectiveness of laparoscopic cholecystectomy guided by ICG.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICG fluorescence guided group | – | Procedure: emergency laparoscopic cholecystectomy guided by indocyanine green (ICG) fluorescencePatients with acute cholecystitis underwent emergent laparscopic cholecystectomy guided by indocyanine green (ICG) fluorescence. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with acute cholecystitis warrant emergent laparscopic cholecystectomy.
Key inclusion criteria (1 listed)
- All of the hospitalized patients of underwent emergent laparscopic cholecystectomy guided by ICG fluorescence by the emergent surgeon team from 1st August 2023 to 1st Feburary 2024 in the department of Emergency in Peking Union Medical College Hospital
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 |
|---|---|---|
| emergency laparoscopic cholecystectomy guided by indocyanine green (ICG) fluorescenceemergency laparoscopic cholecystectomy guided by indocyanine green (ICG) fluorescence | Procedure or surgery | ICG fluorescence guided group |
Primary outcome
incidence of intraoperative accidental bile tract injury
Time frame: within 1 month after after discharge
The primary outcome is incidence of intraoperative accidental injury involving the bile tract in emergent laparscopic cholecystectomy 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 postoperative complications
Time frame: within 1 month after discharge
incidence of complications staging 2 and above according to Clavien Dindo Grade during hospital stay
1 secondary outcome
duration of postoperative hospital stay
Time frame: within 1 month after discharge
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 12 Aug 2024.
- Individual participant dataSharing planned: No
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 principal investigator
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 Cholestatic Hepatitis, 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 12 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 after after discharge). 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 12 Aug 2024.