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Intra-gallbladder or Systemic Indocyanide Green Injection Facilitate Cholecystectomy.

NCT03024892 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2018-07-23

No results posted yet for this study

Summary

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 .

Conditions

  • Fluorenscent Image Guided Surgery
  • Indocyanide Green

Interventions

PROCEDURE

ICG GB

ICG was given by intra-gallbladder injection, then the near-infrared image guide laparoscopic cholecystectomy were performed.

PROCEDURE

ICG IV

ICG was given by systemic injection, then the near-infrared image guide laparoscopic cholecystectomy were performed.

PROCEDURE

LC conventional

simple laparoscopic cholecystectomy was performed under white light image.

PROCEDURE

LC conventional and IOC

simple laparoscopic cholecystectomy was performed under white light image and intraoperaitve cholangiography guidance.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Chien-Hung Liao, MD · Chang Gung Memorial Hospital

  • Shang-Yu Wang, MD · Chang Gung Memorial Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2018-10-31
Completion
2018-10-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03024892 on ClinicalTrials.gov