Safety of Laparoscopic ChOlecystectomy Performed by Trainee Surgeons With Different CHolangiographic Techniques

NCT04863482 | Unknown DMC

• 1 other identifier: UPolitecnicaDM
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic cholecystectomy (LC) gained popularity among general surgeons in 1990s and rapidly become one of the most commonly performed procedures in digestive surgery, with more than one million cholecystectomies being performed in the United States per year. LC remains also one of the most commonly performed procedure by general surgeons during the training period. Even if previous report LC cases performed by surgical trainees (ST) are not associated with higher operative morbidity, the length of operative time is significantly increased when compared with that of LC cases performed by attending surgeons, due, most of all, to difficulties in identifying the anatomical structure, and this sometimes leads to an attending surgeon taking away the case from the trainee. Furthermore, despite the fact that LC has proven to be a safe procedure, the rate of common bile duct (BDI) injury still remains unacceptably high even in the hands of minimally invasive trained surgeons ranging from 0.2 to 1.5% in individual reports, much higher than initial reports, associated with significant morbidity and mortality, lower quality of life and increased costs, related to additional health care measures, loss of work days, and insurance claims. The aim of this study is to address which of the techniques now available could be addressed as the best option in a training setting to enhance the learning curve, to ideally build a safe cholecystectomy training program and virtually eliminate the risk of BDI due to anatomic misinterpretation during the training period.

Conditions

Cholecystitis; Gallstone

Outcome Measures

Primary Outcomes (1)

• Time to obtain the CVS during laparoscopic cholecystectomy

  The primary objective is to compare NIFC, IOC and CVS-WL for identification of the junction between the cystic duct, the common hepatic duct and the CBD during LC performed by general surgery trainee always supported by an expert surgeon. The technique will be considered successful when the CVS will be achieved. The time to achieve the CVS will be recorded by an independent surgeon who will be present in the operative room during the procedure

  operative period

Secondary Outcomes (10)

• length of hospital stay

  through study completion, an average of 1 year

• short term complications (reported with a descriptive name of scale and entered in an excel sheet)

  up to 30 days from operation

• Operative time

  operative period

• Intraoperative complications will be recorded namely as a descriptive variable and at the end of the study the frequency of each complication will be reported

  operative period

• Need for conversion will be reported as a binomial variable and participants will be asked to feel the appropriate spaces with a 1 for yes and 0 for no, at the end the frequency of conversion occurrence will be provided

  operative period

Other Outcomes (2)

• Surgeon's satisfaction

  operative period

• Surgeon's task load

  operative period

Study Arms (3)

Critical view of Safety (CVS-WL)

ACTIVE COMPARATOR

Group CVS-WL (control group): the visualization of the biliary tree is achieved in white light, without the utilization of an intraoperative imaging technique, the CVS in white light was selected as the control group since it constitutes the actual recognized standard in clinical practice.

Procedure: IOC

Intra-operative Cholangiography (IOC)

EXPERIMENTAL

Group IOC: the visualization of the biliary tree is achieved with the help of intraoperative cholangiography

Procedure: IOC

Near-Infra Red Cholangiography (NIR-C)

EXPERIMENTAL

Group NIR-C: the visualization of the biliary tree is achieved with the help of near-infrared fluorescence cholangiography

Procedure: IOC

Interventions

IOC PROCEDURE

intra-operative cholangiography near-infrared fluorescence cholangiography

Also known as: NIR-C

Critical view of Safety (CVS-WL); Intra-operative Cholangiography (IOC); Near-Infra Red Cholangiography (NIR-C)

Eligibility Criteria

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

You may qualify if:

• Patient scheduled for elective laparoscopic cholecystectomy
• Patient age ≥ 18 years
• Patient able to give consent to the procedure

You may not qualify if:

• Open cholecystectomy
• Emergency laparoscopic cholecystectomy
• Allergy towards iodine or indocyanine green
• Liver or renal insufficiency
• Thyrotoxicosis
• Pregnancy or lactation
• Legally incompetent for any reason

Sponsors & Collaborators

• Università Politecnica delle Marche: lead

Study Sites (1)

Università Politecnica delle Marche, Clinica Chirurgica

Ancona, 60126, Italy

RECRUITING

Related Publications (26)

• Way LW, Stewart L, Gantert W, Liu K, Lee CM, Whang K, Hunter JG. Causes and prevention of laparoscopic bile duct injuries: analysis of 252 cases from a human factors and cognitive psychology perspective. Ann Surg. 2003 Apr;237(4):460-9. doi: 10.1097/01.SLA.0000060680.92690.E9.

  PMID: 12677139 BACKGROUND

• Pucher PH, Brunt LM, Fanelli RD, Asbun HJ, Aggarwal R. SAGES expert Delphi consensus: critical factors for safe surgical practice in laparoscopic cholecystectomy. Surg Endosc. 2015 Nov;29(11):3074-85. doi: 10.1007/s00464-015-4079-z. Epub 2015 Feb 11.

  PMID: 25669635 BACKGROUND

• CHERRICK GR, STEIN SW, LEEVY CM, DAVIDSON CS. Indocyanine green: observations on its physical properties, plasma decay, and hepatic extraction. J Clin Invest. 1960 Apr;39(4):592-600. doi: 10.1172/JCI104072. No abstract available.

  PMID: 13809697 BACKGROUND

• Blom EM, Verdaasdonk EG, Stassen LP, Stassen HG, Wieringa PA, Dankelman J. Analysis of verbal communication during teaching in the operating room and the potentials for surgical training. Surg Endosc. 2007 Sep;21(9):1560-6. doi: 10.1007/s00464-006-9161-0. Epub 2007 Feb 7.

  PMID: 17285367 BACKGROUND

• Strasberg SM, Hertl M, Soper NJ. An analysis of the problem of biliary injury during laparoscopic cholecystectomy. J Am Coll Surg. 1995 Jan;180(1):101-25. No abstract available.

  PMID: 8000648 BACKGROUND

• Ishizawa T, Bandai Y, Kokudo N. Fluorescent cholangiography using indocyanine green for laparoscopic cholecystectomy: an initial experience. Arch Surg. 2009 Apr;144(4):381-2. doi: 10.1001/archsurg.2009.9. No abstract available.

  PMID: 19380655 BACKGROUND

• Photi ES, El-Hadi A, Brown S, Swafe L, Ashford-Wilson S, Barwell J, Koopmans I, Lewis MPN. The Routine Use of Cholangiography for Laparoscopic Cholecystectomy in the Modern Era. JSLS. 2017 Jul-Sep;21(3):e2017.00032. doi: 10.4293/JSLS.2017.00032.

  PMID: 28951654 BACKGROUND

• Ludwig K, Bernhardt J, Steffen H, Lorenz D. Contribution of intraoperative cholangiography to incidence and outcome of common bile duct injuries during laparoscopic cholecystectomy. Surg Endosc. 2002 Jul;16(7):1098-104. doi: 10.1007/s00464-001-9183-6. Epub 2002 Apr 9.

  PMID: 12165830 BACKGROUND

• Flum DR, Koepsell T, Heagerty P, Sinanan M, Dellinger EP. Common bile duct injury during laparoscopic cholecystectomy and the use of intraoperative cholangiography: adverse outcome or preventable error? Arch Surg. 2001 Nov;136(11):1287-92. doi: 10.1001/archsurg.136.11.1287.

  PMID: 11695975 BACKGROUND

• Polat FR, Abci I, Coskun I, Uranues S. The importance of intraoperative cholangiography during laparoscopic cholecystectomy. JSLS. 2000 Apr-Jun;4(2):103-7.

  PMID: 10917115 BACKGROUND

• Lill S, Rantala A, Pekkala E, Sarparanta H, Huhtinen H, Rautava P, Gronroos JM. Elective laparoscopic cholecystectomy without routine intraoperative cholangiography: a retrospective analysis of 1101 consecutive cases. Scand J Surg. 2010;99(4):197-200. doi: 10.1177/145749691009900403.

  PMID: 21159587 BACKGROUND

• Ding GQ, Cai W, Qin MF. Is intraoperative cholangiography necessary during laparoscopic cholecystectomy for cholelithiasis? World J Gastroenterol. 2015 Feb 21;21(7):2147-51. doi: 10.3748/wjg.v21.i7.2147.

  PMID: 25717250 BACKGROUND

• Takada T, Strasberg SM, Solomkin JS, Pitt HA, Gomi H, Yoshida M, Mayumi T, Miura F, Gouma DJ, Garden OJ, Buchler MW, Kiriyama S, Yokoe M, Kimura Y, Tsuyuguchi T, Itoi T, Gabata T, Higuchi R, Okamoto K, Hata J, Murata A, Kusachi S, Windsor JA, Supe AN, Lee S, Chen XP, Yamashita Y, Hirata K, Inui K, Sumiyama Y; Tokyo Guidelines Revision Committee. TG13: Updated Tokyo Guidelines for the management of acute cholangitis and cholecystitis. J Hepatobiliary Pancreat Sci. 2013 Jan;20(1):1-7. doi: 10.1007/s00534-012-0566-y.

  PMID: 23307006 BACKGROUND

• Sajid MS, Leaver C, Haider Z, Worthington T, Karanjia N, Singh KK. Routine on-table cholangiography during cholecystectomy: a systematic review. Ann R Coll Surg Engl. 2012 Sep;94(6):375-80. doi: 10.1308/003588412X13373405385331.

  PMID: 22943325 BACKGROUND

• Soper NJ, Dunnegan DL. Routine versus selective intra-operative cholangiography during laparoscopic cholecystectomy. World J Surg. 1992 Nov-Dec;16(6):1133-40. doi: 10.1007/BF02067079.

  PMID: 1455885 BACKGROUND

• Pesce A, Latteri S, Barchitta M, Portale TR, Di Stefano B, Agodi A, Russello D, Puleo S, La Greca G. Near-infrared fluorescent cholangiography - real-time visualization of the biliary tree during elective laparoscopic cholecystectomy. HPB (Oxford). 2018 Jun;20(6):538-545. doi: 10.1016/j.hpb.2017.11.013. Epub 2017 Dec 29.

  PMID: 29292071 BACKGROUND

• Pesce A, Piccolo G, La Greca G, Puleo S. Utility of fluorescent cholangiography during laparoscopic cholecystectomy: A systematic review. World J Gastroenterol. 2015 Jul 7;21(25):7877-83. doi: 10.3748/wjg.v21.i25.7877.

  PMID: 26167088 BACKGROUND

• Agnus V, Pesce A, Boni L, Van Den Bos J, Morales-Conde S, Paganini AM, Quaresima S, Balla A, La Greca G, Plaudis H, Moretto G, Castagnola M, Santi C, Casali L, Tartamella L, Saadi A, Picchetto A, Arezzo A, Marescaux J, Diana M. Fluorescence-based cholangiography: preliminary results from the IHU-IRCAD-EAES EURO-FIGS registry. Surg Endosc. 2020 Sep;34(9):3888-3896. doi: 10.1007/s00464-019-07157-3. Epub 2019 Oct 7.

  PMID: 31591654 BACKGROUND

• Liu Y, Peng Y, Su S, Fang C, Qin S, Wang X, Xia X, Li B, He P. A meta-analysis of indocyanine green fluorescence image-guided laparoscopic cholecystectomy for benign gallbladder disease. Photodiagnosis Photodyn Ther. 2020 Dec;32:101948. doi: 10.1016/j.pdpdt.2020.101948. Epub 2020 Aug 6.

  PMID: 32771612 BACKGROUND

• Quaresima S, Balla A, Palmieri L, Seitaj A, Fingerhut A, Ursi P, Paganini AM. Routine near infra-red indocyanine green fluorescent cholangiography versus intraoperative cholangiography during laparoscopic cholecystectomy: a case-matched comparison. Surg Endosc. 2020 May;34(5):1959-1967. doi: 10.1007/s00464-019-06970-0. Epub 2019 Jul 15.

  PMID: 31309307 BACKGROUND

• Lehrskov LL, Westen M, Larsen SS, Jensen AB, Kristensen BB, Bisgaard T. Fluorescence or X-ray cholangiography in elective laparoscopic cholecystectomy: a randomized clinical trial. Br J Surg. 2020 May;107(6):655-661. doi: 10.1002/bjs.11510. Epub 2020 Feb 14.

  PMID: 32057103 BACKGROUND

• Sariego J, Spitzer L, Matsumoto T. The "learning curve" in the performance of laparoscopic cholecystectomy. Int Surg. 1993 Jan-Mar;78(1):1-3.

  PMID: 8473074 BACKGROUND

• Hawasli A, Lloyd LR. Laparoscopic cholecystectomy. The learning curve: report of 50 patients. Am Surg. 1991 Aug;57(8):542-4; discussion 545.

  PMID: 1834000 BACKGROUND

• Moore MJ, Bennett CL. The learning curve for laparoscopic cholecystectomy. The Southern Surgeons Club. Am J Surg. 1995 Jul;170(1):55-9. doi: 10.1016/s0002-9610(99)80252-9.

  PMID: 7793496 BACKGROUND

• Cagir B, Rangraj M, Maffuci L, Herz BL. The learning curve for laparoscopic cholecystectomy. J Laparoendosc Surg. 1994 Dec;4(6):419-27. doi: 10.1089/lps.1994.4.419.

  PMID: 7881146 BACKGROUND

• Fingerhut A, Dziri C, Garden OJ, Gouma D, Millat B, Neugebauer E, Paganini A, Targarona E. ATOM, the all-inclusive, nominal EAES classification of bile duct injuries during cholecystectomy. Surg Endosc. 2013 Dec;27(12):4608-19. doi: 10.1007/s00464-013-3081-6. Epub 2013 Jul 27.

  PMID: 23892759 BACKGROUND

MeSH Terms

Conditions

Cholecystitis; Gallstones

Condition Hierarchy (Ancestors)

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

Study Officials

• Monica Ortenzi, MD

  Università Politecnica delle Marche

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica Ortenzi, MD

CONTACT

0039 3924770853; monica.ortenzi@gmail.com

Mario Guerrieri, MD

CONTACT

00390715963084; guerrieri.m@libero.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 28, 2021
• Study Start: June 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: October 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)