Norwegian Randomized Trial on Indocyanine Green Cholangiography Utility for Laparoscopic Cholecystectomy, Prestudy

NCT05376540 | Unknown

• 1 other identifier: REK280193
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare different dosages and ways of administration of indocyanine green during fluorescent cholangiography in laparoscopic cholecystectomy. The study is randomized.

Conditions

Gall Stone; Cholecystitis

Keywords

Cholecystectomy; Flourescent cholangiography

Outcome Measures

Primary Outcomes (1)

• A questionnaire will be used to evaluate the surgeons experience.

  This study aims to compare the surgeons subjective experience of ICG utility for different dosages and route of administration of indocyanine green in patients operated with laparoscopic cholecystectomy. A questionnaire will be used to evaluate the surgeons experience.

  3-4 months

Study Arms (4)

Direct gallbladder injection

OTHER

2.5 mg of ICG will be injected directly into gallbladder intraoperatively.

Procedure: Direct gallbladder injection of ICG intraoperatively

2.5 mg intravenously

OTHER

2.5 mg will ICG will be injected intravenously 1 hour prior to surgery.

Procedure: Intravenous injection 2.5 mg

2.5 mg intravenously + direct gallbladder injection

OTHER

2.5 mg ICG will be injected intravenously 1 hour prior to surgery and another 2.5 mg ICG will be injected directly into the gallbladder intraoperatively.

Procedure: Intravenous injection and direct gallbladder injection

5 mg intravenously

OTHER

5 mg ICG will be injected intravenously 0-8 hours prior to surgery.

Procedure: Intravenous injection 5 mg

Interventions

Direct gallbladder injection of ICG intraoperatively PROCEDURE

Patients randomized to this arm will have 2.5 mg ICG injected directly into the gallbladder intraoperatively.

Direct gallbladder injection

Intravenous injection 2.5 mg PROCEDURE

Patients randomized to this arm will have 2.5 mg ICG injected intravenously 1 hour prio to surgery

2.5 mg intravenously

Intravenous injection and direct gallbladder injection PROCEDURE

Patients randomized to this arm will have 2.5 mg ICG injected intravenously 1 hour prior to surgery and another 2.5 mg ICG injected directly into the gallbladder, intraoperatively.

2.5 mg intravenously + direct gallbladder injection

Intravenous injection 5 mg PROCEDURE

Patients randomized to this arm will have 5 mg ICG injected intravenously 0-8 hours prior to surgery

5 mg intravenously

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication for laparoscopic cholecystectomy
• Signed informed consent

You may not qualify if:

• Allergy to indocyanine green or iodine
• Pregnancy or breast feeding

Sponsors & Collaborators

• Ostfold Hospital Trust: lead
• Oslo University Hospital: collaborator

Study Sites (1)

Østfold Hospital trust

Moss, Norway

RECRUITING

MeSH Terms

Conditions

Gallstones; Cholecystitis

Interventions

Injections, Intravenous

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Injections

Study Officials

• Tom Nordby, MD, PhD

  Ostfold Hospital Trust, Norway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carl-Philip Rancinger, MD

CONTACT

+4769860000; carl-philip.rancinger@so-hf.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: May 17, 2022
• Study Start: March 3, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)