Indocyanine Green Fluorescence in Evaluation of Pancreatic Remnant Perfusion.

Pancreatic Fistula Clinical Trial

Official title:

Indocyanine Green Fluorescence in Evaluation of Post-resection Pancreatic Remnant Perfusion After Pancreaticoduodenectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06198400
• Other study ID #: MO1012
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: July 1, 2027

Study information

• Verified date: January 2024
• Source: Charles University, Czech Republic
• Contact: Štepán-Ota Schutz
• Phone: +420 7332 24 640
• Email: stepan.sch[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Main goal of this study is to evaluate the blood flow in a post resection pancreatic remnant after pancreaticoduodenectomy with use of indocyanine green fluorescence. If the hypothesis will be proven, evaluation of perfusion of the pancreatic remnant with indocyanine green could be used to estimate the increased risk of the development of pancreatic fistula.

Description:

Pancreatoduodenectomy is associated with nearly 25% incidence of postoperative complications. One of the most severe complications is a postoperative pancreatic fistula. The exact cause of postoperative fistula development is still unknown, but it appears to be multifactorial. Proper perfusion of pancreatic remnant is essential for the healing of pancreaticojejunostomy. To date, there is no method to reliably evaluate the vascular supply of the remnant. One of the methods for assessment of organ perfusion is the indocyanine green fluorescence. This study aims to determine if indocyanine green fluorescence is a reliable method to measure the perfusion of the post-resection pancreatic remnant. Secondary outcome is to determine, if perioperative evaluation of the vascular supply of the postresection remnant may predict the increased risk of the postoperative pancreatic fistula development.

This study is designed as a prospective experimental study. All consecutive patients undergoing open pancreaticoduodenectomy at our department in the 1.5.2024-31.12.2026 period will be enrolled. Exclusion criteria are allergy to indocyanine green and refusal by the patient.The adequacy of the vascular supply of the post-resection pancreatic remnant will be perioperatively evaluated using fluorescence detector. Patients will be divided into two groups. Those with hazardous and non-hazardous vascular supply. The incidence of pancreatic fistula in both groups is to be compared. Postoperative data including morbidity, mortality, hospital stay, intensive care unit stay and postoperative fistula development will be collected.

If a perioperative assessment of the perfusion of post-resection pancreatic remnant using indocyanine green is proven to be a suitable method to estimate the increased risk of the pancreatic fistula, the list of the existing known risk factors could be expanded. In the most high-risk patients the modification of the surgical procedure could be considered.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All consecutive patients undergoing open pancreaticoduodenectomy at our department in the selected period

Exclusion Criteria:

• Allergy to indocyanine green

• Refusal by the patient

• Mini-invasive procedure.

Related Conditions & MeSH terms

• Fistula
• Pancreatic Fistula

Intervention

Diagnostic Test:
• Perioperative assessment of the perfusion of post-resection pancreatic remnant using indocyanine green-VerDye
The adequacy of the vascular supply of the post resection pancreatic remnant after pancreatic neck division will be evaluated using ICG detector. Indocyanine green fluorescence product -Verdye™ will be intravenously applied. The application of the substance will be performed according to the current consensus statement and recommendation

Locations

Country	Name	City	State
Czechia	Department of Surgery, Second Faculty of Medicine of Charles University and Military University Hospital Prague, Czech Republic	Prag	Czech Republic

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

References & Publications (20)

Baiocchi GL, Diana M, Boni L. Indocyanine green-based fluorescence imaging in visceral and hepatobiliary and pancreatic surgery: State of the art and future directions. World J Gastroenterol. 2018 Jul 21;24(27):2921-2930. doi: 10.3748/wjg.v24.i27.2921. — View Citation

Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe — View Citation

Bengtsson A, Andersson R, Ansari D. The actual 5-year survivors of pancreatic ductal adenocarcinoma based on real-world data. Sci Rep. 2020 Oct 2;10(1):16425. doi: 10.1038/s41598-020-73525-y. — View Citation

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. E — View Citation

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. — View Citation

de Muynck LDAN, White KP, Alseidi A, Bannone E, Boni L, Bouvet M, Falconi M, Fuchs HF, Ghadimi M, Gockel I, Hackert T, Ishizawa T, Kang CM, Kokudo N, Nickel F, Partelli S, Rangelova E, Swijnenburg RJ, Dip F, Rosenthal RJ, Vahrmeijer AL, Mieog JSD. Consens — View Citation

Degett TH, Andersen HS, Gogenur I. Indocyanine green fluorescence angiography for intraoperative assessment of gastrointestinal anastomotic perfusion: a systematic review of clinical trials. Langenbecks Arch Surg. 2016 Sep;401(6):767-75. doi: 10.1007/s004 — View Citation

Doussot A, Decrock M, Calame P, Georges P, Turco C, Lakkis Z, Heyd B. Fluorescence-based pancreas stump perfusion is associated with postoperative acute pancreatitis after pancreatoduodenectomy a prospective cohort study. Pancreatology. 2021 May 18:S1424- — View Citation

Fuks D, Piessen G, Huet E, Tavernier M, Zerbib P, Michot F, Scotte M, Triboulet JP, Mariette C, Chiche L, Salame E, Segol P, Pruvot FR, Mauvais F, Roman H, Verhaeghe P, Regimbeau JM. Life-threatening postoperative pancreatic fistula (grade C) after pancre — View Citation

Gaujoux S, Cortes A, Couvelard A, Noullet S, Clavel L, Rebours V, Levy P, Sauvanet A, Ruszniewski P, Belghiti J. Fatty pancreas and increased body mass index are risk factors of pancreatic fistula after pancreaticoduodenectomy. Surgery. 2010 Jul;148(1):15 — View Citation

Hackethal A, Hirschburger M, Eicker SO, Mucke T, Lindner C, Buchweitz O. Role of Indocyanine Green in Fluorescence Imaging with Near-Infrared Light to Identify Sentinel Lymph Nodes, Lymphatic Vessels and Pathways Prior to Surgery - A Critical Evaluation o — View Citation

Hu BY, Wan T, Zhang WZ, Dong JH. Risk factors for postoperative pancreatic fistula: Analysis of 539 successive cases of pancreaticoduodenectomy. World J Gastroenterol. 2016 Sep 14;22(34):7797-805. doi: 10.3748/wjg.v22.i34.7797. — View Citation

Karim SAM, Abdulla KS, Abdulkarim QH, Rahim FH. The outcomes and complications of pancreaticoduodenectomy (Whipple procedure): Cross sectional study. Int J Surg. 2018 Apr;52:383-387. doi: 10.1016/j.ijsu.2018.01.041. Epub 2018 Feb 10. — View Citation

Keller DS, Ishizawa T, Cohen R, Chand M. Indocyanine green fluorescence imaging in colorectal surgery: overview, applications, and future directions. Lancet Gastroenterol Hepatol. 2017 Oct;2(10):757-766. doi: 10.1016/S2468-1253(17)30216-9. — View Citation

Marchegiani G, Perri G, Burelli A, Zoccatelli F, Andrianello S, Luchini C, Donadello K, Bassi C, Salvia R. High-risk Pancreatic Anastomosis Versus Total Pancreatectomy After Pancreatoduodenectomy: Postoperative Outcomes and Quality of Life Analysis. Ann S — View Citation

Nahm CB, Connor SJ, Samra JS, Mittal A. Postoperative pancreatic fistula: a review of traditional and emerging concepts. Clin Exp Gastroenterol. 2018 Mar 15;11:105-118. doi: 10.2147/CEG.S120217. eCollection 2018. — View Citation

Pedrazzoli S. Pancreatoduodenectomy (PD) and postoperative pancreatic fistula (POPF): A systematic review and analysis of the POPF-related mortality rate in 60,739 patients retrieved from the English literature published between 1990 and 2015. Medicine (B — View Citation

Rawla P, Sunkara T, Gaduputi V. Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors. World J Oncol. 2019 Feb;10(1):10-27. doi: 10.14740/wjon1166. Epub 2019 Feb 26. — View Citation

Rousek M, Whitley A, Kachlik D, Balko J, Zaruba P, Belbl M, Nikov A, Ryska M, Gurlich R, Pohnan R. The dorsal pancreatic artery: A meta-analysis with clinical correlations. Pancreatology. 2022 Mar;22(2):325-332. doi: 10.1016/j.pan.2022.02.002. Epub 2022 F — View Citation

Strasberg SM, Drebin JA, Mokadam NA, Green DW, Jones KL, Ehlers JP, Linehan D. Prospective trial of a blood supply-based technique of pancreaticojejunostomy: effect on anastomotic failure in the Whipple procedure. J Am Coll Surg. 2002 Jun;194(6):746-58; d — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the blood flow in pancreatic remnant with use of ICG	Primary outcome of this study is to evaluate the blood flow in a post resection pancreatic remnant after pancreaticoduodenectomy with use of ICG fluorescence.	Intraoperatively: 5-10 minutes
Secondary	Correlation between ICG perfusion and development of pancreatic fistula	Secondary outcome of this study is to find possible correlation between ICG finding and higher rate of postoperative pancreatic fistula development which could lead to establishment of new predictive risk factor.	From admission to discharge, up to 2 weeks

External Links

•   Indocyanine Green-Fluorescent Pancreatic Perfusion-Guided Resection of Distal Pancreas in Solid Pseudopapillary Neoplasm: Usefulness and Feasibility During Pancreaticobiliary Surgery