Comparison of Icg's Route of Administration During Laparoscopic Cholecystectomy

NCT04908826 | Unknown DMC

• 1 other identifier: 3765/03.02.2020
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the trial is to compare the routes of administration of indocyanine green (ICG) during laparoscopic cholocystectomy.

Conditions

Laparoscopic; Cholecystectomy; Cholelithiasis; Bile Duct; Choledocholithiasis; Stone - Biliary; Post-Op Complication; Cholangiography; Indocyanine Green; Intraoperative Complications; Bile Duct Injury

Outcome Measures

Primary Outcomes (5)

• successful imaging of biliary system

  The anatomy of the extrahepatic bile ducts will be orally determined by the surgeon and the cases in which the oral description will coincide with the findings of cholangiography or not and where there were differences will be recorded.

  intra-operatively

• operation duration

  minutes

  intra-operatively

• intra-operative complications (bleeding, bile duct leakage, bile duct injury)

  presence or absence

  intra-operatively

• applicability of the intra-operatively cholangiography

  yes or no

  intra-operatively

• presence of bile duct stones (choledocholithiasis)

  yes or no

  intra-operatively

Secondary Outcomes (23)

• gender

  pre-operatively

• ASA score

  pre-operatively

• age

  pre-operatively

• body mass index

  pre-operatively

• indication for laparoscopic cholecystectomy

  pre-operatively

Study Arms (3)

Group A (standard cholangiography during surgery)

ACTIVE COMPARATOR

All patients will undergo laparoscopic cholecystectomy. In this group standard cholangiography will be performed during surgery. Standard cholangiography will be performed with selective catheterization of the cystic duct and infusion of a radiolucent substance (non-ionic low osmotic iodine). The category includes drugs such as iohexol, iopamidol, iopromide, ioversol, iobitriol, iomeprol and iodixanol. In our study we will use Xenetix (iobitriol) and perform cholangiography with C-ARM recording.

Procedure: Indocyanine Green (ICG) administration

Group B (cholangiography with iv administration of icg prior to surgery)

ACTIVE COMPARATOR

All patients will undergo laparoscopic cholecystectomy. In this group intravenous fluorescent cholangiography with indocyanine green will be given at a dose of 0.3 mg / mL / Kg 6 (six) hours before the start of surgery.The bile duct system will be recorded with a special camera (Karl Storz NIR / ICG).

Procedure: Indocyanine Green (ICG) administration

Group C (cholangiography with direct administration of icg to the bile duct system during surgery)

ACTIVE COMPARATOR

All patients will undergo laparoscopic cholecystectomy. In the third group intraoperative cholangiography will be performed with direct administration of indocyanine green at a dose of 0.03 mg / ml / Kg to the bile duct cyst.

Procedure: Indocyanine Green (ICG) administration

Interventions

Indocyanine Green (ICG) administration PROCEDURE

Patients will undergo laparoscopic cholecystectomy after they are randomly divided into 3 (three) groups. A total of 240 patients will be randomized into three groups of 80. In the first group (A) standard cholangiography will be performed. In group (B) intravenous fluorescent cholangiography with indocyanine green will be performed during surgery. ICG at a dose of 0.3 mg / mL / Kg 6 (six) hours prior to surgery will be administered. In the third group (C), intraoperative cholangiography will be performed with direct administration of indocyanine green at a dose of 0.03 mg / ml / Kg to the gallbladder.

Also known as: laparoscopic cholecystectomy, intra-operative cholangiography, c-arm recording, iodine solution administration

Group A (standard cholangiography during surgery); Group B (cholangiography with iv administration of icg prior to surgery); Group C (cholangiography with direct administration of icg to the bile duct system during surgery)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age older than 18 years old
• laparoscopic cholecystectomy
• elective surgery

You may not qualify if:

• younger than 18 years old
• no consent to participate to the study
• history of allergic reaction to iodine products
• urgent or emergent cholecystectomy

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• George Papanicolaou Hospital: collaborator

Study Sites (1)

General Hospital of Thessaloniki "G. Papanikolaou"

Thessaloniki, 57010, Greece

RECRUITING

Related Publications (9)

• Costi R, Gnocchi A, Di Mario F, Sarli L. Diagnosis and management of choledocholithiasis in the golden age of imaging, endoscopy and laparoscopy. World J Gastroenterol. 2014 Oct 7;20(37):13382-401. doi: 10.3748/wjg.v20.i37.13382.

  PMID: 25309071 BACKGROUND

• Duca S, Bala O, Al-Hajjar N, Lancu C, Puia IC, Munteanu D, Graur F. Laparoscopic cholecystectomy: incidents and complications. A retrospective analysis of 9542 consecutive laparoscopic operations. HPB (Oxford). 2003;5(3):152-8. doi: 10.1080/13651820310015293.

  PMID: 18332976 BACKGROUND

• Al-Mulhim AA. Current trends in laparoscopic cholecystectomy. J Family Community Med. 1997 Jul;4(2):33-40.

  PMID: 23008571 BACKGROUND

• Duncan CB, Riall TS. Evidence-based current surgical practice: calculous gallbladder disease. J Gastrointest Surg. 2012 Nov;16(11):2011-25. doi: 10.1007/s11605-012-2024-1. Epub 2012 Sep 18.

  PMID: 22986769 BACKGROUND

• Alander JT, Kaartinen I, Laakso A, Patila T, Spillmann T, Tuchin VV, Venermo M, Valisuo P. A review of indocyanine green fluorescent imaging in surgery. Int J Biomed Imaging. 2012;2012:940585. doi: 10.1155/2012/940585. Epub 2012 Apr 22.

  PMID: 22577366 BACKGROUND

• Boni L, David G, Mangano A, Dionigi G, Rausei S, Spampatti S, Cassinotti E, Fingerhut A. Clinical applications of indocyanine green (ICG) enhanced fluorescence in laparoscopic surgery. Surg Endosc. 2015 Jul;29(7):2046-55. doi: 10.1007/s00464-014-3895-x. Epub 2014 Oct 11.

  PMID: 25303914 BACKGROUND

• Ambe PC, Plambeck J, Fernandez-Jesberg V, Zarras K. The role of indocyanine green fluoroscopy for intraoperative bile duct visualization during laparoscopic cholecystectomy: an observational cohort study in 70 patients. Patient Saf Surg. 2019 Jan 12;13:2. doi: 10.1186/s13037-019-0182-8. eCollection 2019.

  PMID: 30651756 BACKGROUND

• Chu W, Chennamsetty A, Toroussian R, Lau C. Anaphylactic Shock After Intravenous Administration of Indocyanine Green During Robotic Partial Nephrectomy. Urol Case Rep. 2017 Mar 10;12:37-38. doi: 10.1016/j.eucr.2017.02.006. eCollection 2017 May.

  PMID: 28316935 BACKGROUND

• Hope-Ross M, Yannuzzi LA, Gragoudas ES, Guyer DR, Slakter JS, Sorenson JA, Krupsky S, Orlock DA, Puliafito CA. Adverse reactions due to indocyanine green. Ophthalmology. 1994 Mar;101(3):529-33. doi: 10.1016/s0161-6420(94)31303-0.

  PMID: 8127574 BACKGROUND

MeSH Terms

Conditions

Cholelithiasis; Choledocholithiasis; Cholecystolithiasis; Postoperative Complications; Intraoperative Complications

Interventions

Indocyanine Green; Organization and Administration; Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Common Bile Duct Diseases; Bile Duct Diseases; Gallbladder Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Health Services Administration; Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

Study Officials

• Savvas Simeonidis, MD, PhD(c)

  General Hospital of Thessaloniki "G. Papanikolaou", Aristotle University of Thessaloniki

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Savvas Simeonidis, MD, PhD(c)

CONTACT

698 0309611; simeonidissavvas@yahoo.com

Panagiotis Christidis, MD, MSc

CONTACT

6940730227; panagiotischristidis13@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: June 1, 2021
• Study Start: January 3, 2022
• Primary Completion: June 1, 2022
• Study Completion: January 1, 2023
• Last Updated: March 10, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)