NCT06198400

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
14mo left

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
May 2024Jul 2027

First Submitted

Initial submission to the registry

December 6, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

2.7 years

First QC Date

December 6, 2023

Last Update Submit

August 19, 2024

Conditions

Pancreatic Fistula

Keywords

Pancreatic surgeryICGMinimal invasive surgery,Pancreatic cancerPancreatic perfusion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Correlation between ICG perfusion and development of pancreatic fistula

    From admission to discharge, up to 2 weeks

Study Arms (1)

All patients undergoing the pancreaticoduodenectomy

EXPERIMENTAL

All consecutive patients undergoing the pancreaticoduodenectomy at our institution in the 1.5.2024-31.12.2026 period will be enrolled in this study.

Diagnostic Test: Perioperative assessment of the perfusion of post-resection pancreatic remnant using indocyanine green-VerDye

Interventions

Perioperative assessment of the perfusion of post-resection pancreatic remnant using indocyanine green-VerDyeDIAGNOSTIC_TEST

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

All patients undergoing the pancreaticoduodenectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Allergy to indocyanine green
  • Refusal by the patient
  • Mini-invasive procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Second Faculty of Medicine of Charles University and Military University Hospital Prague, Czech Republic

Prague, Czech Republic, 16000, Czechia

RECRUITING

Related Publications (21)

  • 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.

    PMID: 30834048RESULT

  • 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.

    PMID: 29438817RESULT

  • 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 Feb 11.

    PMID: 35177332RESULT

  • 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.

    PMID: 29588609RESULT

  • 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 KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CM, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28.

    PMID: 28040257RESULT

  • 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.

    PMID: 33009477RESULT

  • 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. Consensus Statement on the Use of Near-Infrared Fluorescence Imaging during Pancreatic Cancer Surgery Based on a Delphi Study: Surgeons' Perspectives on Current Use and Future Recommendations. Cancers (Basel). 2023 Jan 20;15(3):652. doi: 10.3390/cancers15030652.

    PMID: 36765609RESULT

  • 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; discussion 759-60. doi: 10.1016/s1072-7515(02)01202-4.

    PMID: 12081065RESULT

  • 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: 25303914RESULT

  • 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: 13809697RESULT

  • 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.

    PMID: 28895551RESULT

  • 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 of Options. Geburtshilfe Frauenheilkd. 2018 Jan;78(1):54-62. doi: 10.1055/s-0043-123937. Epub 2018 Jan 22.

    PMID: 29375146RESULT

  • 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/s00423-016-1400-9. Epub 2016 Mar 11.

    PMID: 26968863RESULT

  • 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 Sep;21(6):1023-1029. doi: 10.1016/j.pan.2021.05.009. Epub 2021 May 18.

    PMID: 34030965RESULT

  • 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 Surg. 2022 Dec 1;276(6):e905-e913. doi: 10.1097/SLA.0000000000004840. Epub 2021 Mar 4.

    PMID: 33914471RESULT

  • 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.

    PMID: 30038461RESULT

  • 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.

    PMID: 27678363RESULT

  • 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 pancreaticoduodenectomy: incidence, prognosis, and risk factors. Am J Surg. 2009 Jun;197(6):702-9. doi: 10.1016/j.amjsurg.2008.03.004. Epub 2008 Sep 7.

    PMID: 18778804RESULT

  • 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):15-23. doi: 10.1016/j.surg.2009.12.005.

    PMID: 20138325RESULT

  • 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 (Baltimore). 2017 May;96(19):e6858. doi: 10.1097/MD.0000000000006858.

    PMID: 28489778RESULT

  • Schutz SO, Rousek M, Zaruba P, Husarova T, Pohnan R. Indocyanine green fluorescence in the evaluation of post-resection pancreatic remnant perfusion after a pancreaticoduodenectomy: a clinical study protocol. BMC Surg. 2024 Sep 14;24(1):261. doi: 10.1186/s12893-024-02559-0.

    PMID: 39272087DERIVED

Related Links

MeSH Terms

Conditions

Pancreatic FistulaPancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System FistulaDigestive System DiseasesPancreatic DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsEndocrine System Diseases

Study Officials

  • Radek Pohnán

    Department of Surgery, Second Faculty of Medicine of Charles University and Military University Hospital Prague, Czech Republic

    STUDY DIRECTOR

Central Study Contacts

Štěpán-Ota Schutz

CONTACT

+420 7332 24 640schutz.stepan-ota@uvn.cz

Michael Rousek

CONTACT

+420 973 202 903Michael.Rousek@uvn.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Surgical resident, Postgraduate student

Study Record Dates

First Submitted

December 6, 2023

First Posted

January 10, 2024

Study Start

May 1, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

August 21, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations

CZ(1)