Emergent Laparoscopic Cholecystectomy With ICG Cholangiography (ELG-ICGC)
Emergency Laparoscopic Cholecystectomy Guided by Indocyanine Green (ICG) Fluorescence: a Single Center Experience
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Beijing
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Beijing, Beijing, China, 100730
- Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients with incomplete medical records. Patients have other emergent conditions which warrant other emergent operations or major treatment simultaneously besides ELC.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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ICG fluorescence guided group
Patients with acute cholecystitis underwent emergent laparscopic cholecystectomy guided by indocyanine green (ICG) fluorescence.
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emergency laparoscopic cholecystectomy guided by indocyanine green (ICG) fluorescence
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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incidence of intraoperative accidental bile tract injury
Time Frame: within 1 month after after discharge
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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.
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within 1 month after after discharge
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incidence of postoperative complications
Time Frame: within 1 month after discharge
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incidence of complications staging 2 and above according to Clavien Dindo Grade during hospital stay
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within 1 month after discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
duration of postoperative hospital stay
Time Frame: within 1 month after discharge
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Days of postoperative hospital stay
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within 1 month after discharge
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Collaborators and Investigators
Investigators
- Principal Investigator: Qiaofei Liu, M.D, Department of General Surgery, Peking Union Medical College Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- K5730-K24C2175
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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