Intra-gallbladder or Systemic Indocyanide Green Injection Facilitate Cholecystectomy.

July 19, 2018 updated by: Chang Gung Memorial Hospital

Intra-gallbladder or Systemic Indocyanide Green Injection Facilitate Cholecystectomy in Acute Cholecystitis , Gallstone and Gallbladder Polyp Patients.

The investigators will collect the pre-operative medical history and arrange physical examination, life quality evaluation, blood and biochemical test. The Patients with acute cholecytitis, gallstone or gallbladder polyp without interventional treatment or cholecystitis after percurtaneus gallbladder drainage(PTGBD) were involved in this study. Four laparoscopic ports were introduced and the pneumoperitoneum (12mmHg) was established. In study group , ICG was give by intra-gallbladder injection or systemic injection, the cholecystectomy were performed . In control group, no ICG was given and traditional cholecystectomy were performed. A near-infrared optimized laparoscope was used to detect the ICG fluorescence signal arising from gallbladder , cystic duct and common bile duct before cholecystectomy in study group. According to the enhancement of ICG, the cholecystectomy was started from cystic duct in Calot's triangle.Time to gallbladder removed was recorded. Conversion rate, post-operative morbidity and mortality will be recorded as well .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Back Ground:

Laparoscopic cholecystectomy(LC) is the one of most common procedure done by minimal invasive surgery worldwide but the common bile duct(CBD) injury still happened even the existence of standard technique with growing experience and new technology, especial in cholecystitis. Image guided surgery created new concept for fluorescent cholangiography to demonstrate the anatomy of CBD by using indocyanine green (ICG) intravenous injection before operation to decreased complication. The result is positive but the border of gallbladder can't be seen very well in systemic injection . In cholecystitis, the border between gallbladder and common bile duct is important as well as CBD and cystic duct.

Purpose:

The investigators hypothesized injection of ICG into gallbladder directly will be helpful to identify cystic duct, CBD and the border of gallbladder as well as systemic injection . The purpose of this study was to evaluate feasibility of this image guide surgery

Study Design:

The investigators will collect the pre-operative medical history and arrange physical examination, life quality evaluation, blood and biochemical test. The Patients with acute cholecytitis, gallstone or gallbladder polyp without interventional treatment or cholecystitis after percurtaneus gallbladder drainage(PTGBD) were involved in this study. Four laparoscopic ports were introduced and the pneumoperitoneum (12mmHg) was established. In study group , ICG was give by intra-gallbladder injection or systemic injection, the cholecystectomy were performed . In control group, no ICG was given and traditional cholecystectomy were performed. A near-infrared optimized laparoscope was used to detect the ICG fluorescence signal arising from gallbladder , cystic duct and common bile duct before cholecystectomy in study group. According to the enhancement of ICG, the cholecystectomy was started from cystic duct in Calot's triangle. Time to gallbladder removed was recorded. Conversion rate, post-operative morbidity and mortality will be recorded as well . The investigators intend to collect 600 patients. 150 patients will receive ICG injection via gallbladder as image guided surgery, 150 patients will receive ICG injection via systemic injection as image guided surgery , the other 300 patients who refuse will be the control group(150 patients for LC and 150 patients for LC + intra-operative cholangiography).

Expected results A. Publish Intra-gallbladder indocyanide green injection via drainage route facilitate cholecystectomy in acute cholecystitis。 B. Publish Comparison of systemic and intra-gallbladder injection of indocyanide green in benefit for cholecystectomy C. Extend to publish Near-infrared cholangiography decreased learning curve of laparoscopic cholecystectomy for medical student D. Near- infrared laparoscope education textbook and clinical case analysis

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
    • Kaohsiung
      • Niaosong, Kaohsiung, Taiwan, 833
        • Recruiting
        • Chang Gung Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with acute cholecytitis, gallstone or gallbladder polyp without interventional treatment or cholecystitis after percurtaneus gallbladder drainage(PTGBD) were involved in this study.

Exclusion Criteria:

  • a.Pregnancy and Breast feeding female.
  • b.Patients have another severe medical diseases.(ex: heart failure, respiratory failure and stroke etc.)
  • c.Not suitable for patients receiving anesthesia.
  • d.Alcoholism, drug abuse and psychopaths.
  • e.Iodine allergies and renal failure patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICG gallbladder
patients who received ICG injection via gallbladder and received fluroscence image guided surgery
Procedure: ICG GB
ICG was given by intra-gallbladder injection, then the near-infrared image guide laparoscopic cholecystectomy were performed.
Experimental: ICG IV
patients who received ICG injection via peripheral vein and received fluroscence image guided surgery
Procedure: ICG IV
ICG was given by systemic injection, then the near-infrared image guide laparoscopic cholecystectomy were performed.
Sham Comparator: LC conventional
Patients received conventional laparoscopic cholecystectomy
Procedure: LC conventional
simple laparoscopic cholecystectomy was performed under white light image.
Sham Comparator: LC conventional and IOC
Patients received conventional laparoscopic cholecystectomy + intraoperative cholangiography
Procedure: LC conventional and IOC
simple laparoscopic cholecystectomy was performed under white light image and intraoperaitve cholangiography guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hartmann's pouch identification ( white light and infrared fluroscence image)
Time Frame: intra-operative period
evaluation rate the visualization of Hartmann's pouch between two method
intra-operative period
Cystic duct identification ( white light and infrared fluroscence image)
Time Frame: intra-operative period
evaluation rate the visualization of Hartmann's pouch between two method
intra-operative period
CBD identification ( white light and infrared fluroscence image)
Time Frame: intra-operative period
evaluation rate the visualization of Hartmann's pouch between two method
intra-operative period
CHD identification ( white light and infrared fluroscence image)
Time Frame: intra-operative period
evaluation rate the visualization of Hartmann's pouch between two method
intra-operative period
conversion rate
Time Frame: intra-operative period
the rate for calculate the conversion from laparoscopic cholecystectomy to open cholecystectomy
intra-operative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CBD injury
Time Frame: post op day 3
evaluation of clinical S/S for jaundice , if suspect CBD injury then arrange examination
post op day 3
Post op morbidity
Time Frame: Post op day 7
any complication related to surgery
Post op day 7
Post op mortality
Time Frame: Post op day 30
any mortality related to surgery
Post op day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Chien-Hung Liao, MD, Chang Gung Memorial Hospital
  • Principal Investigator: Shang-Yu Wang, MD, Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

January 17, 2017

First Submitted That Met QC Criteria

January 17, 2017

First Posted (Estimate)

January 19, 2017

Study Record Updates

Last Update Posted (Actual)

July 23, 2018

Last Update Submitted That Met QC Criteria

July 19, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CGMH-IRB-104-5333A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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