Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy

NCT07854353 | Not Yet Recruiting DMC

• 1 other identifier: Fistula Risk Score
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Postoperative pancreatic fistula (POPF) especially clinically relevant POPF (CR-POPF; Grades B and C) is one of the critical and challenging post pancreaticoduodenectomy complications. Despite advances in surgical techniques, perioperative care, and centralization of pancreatic surgery Postoperative pancreatic fistula (POPF) remains an important cause for postoperative morbidity and

Conditions

Pancreaticoduodenectomy

Keywords

pancreatic fistula

Outcome Measures

Primary Outcomes (2)

• Incidence of clinically relevant postoperative pancreatic fistula

  Proportion of patients developing clinically relevant postoperative pancreatic fistula (Grade B or C) following pancreaticoduodenectomy, according to the International Study Group of Pancreatic Surgery (ISGPS) definition.

  Within 90 days after surgery

• Discrimination of the preoperative prediction model

  Area under the receiver operating characteristic curve (AUROC) for the preoperative prediction model in predicting clinically relevant postoperative pancreatic fistula.

  Within 90 days after surgery

Study Arms (1)

preoperative risk model for clinically relevant postoperative pancreatic fistula

Procedure: pancreaticoduodenectomy

Interventions

pancreaticoduodenectomy PROCEDURE

preoperative risk model for clinically relevant postoperative pancreatic fistula by incorporation of preoperative PNI and pancreatic texture assessment by elastography with previously emerged scores in patients undergoing pancreaticoduodenectomy

preoperative risk model for clinically relevant postoperative pancreatic fistula

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing elective pancreaticoduodenctomy

You may qualify if:

• Adults (≥18 years).
• Elective pancreaticoduodenectomy.
• Benign or malignant periampullary and pancreatic lesions.

You may not qualify if:

• \- Total pancreatectomy.
• Distal pancreatectomy.
• Missing essential preoperative data.
• Death within 24 hours after surgery.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (10)

• 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: 28040257 BACKGROUND

• Mungroop TH, Klompmaker S, Wellner UF, Steyerberg EW, Coratti A, D'Hondt M, de Pastena M, Dokmak S, Khatkov I, Saint-Marc O, Wittel U, Abu Hilal M, Fuks D, Poves I, Keck T, Boggi U, Besselink MG; European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS). Updated Alternative Fistula Risk Score (ua-FRS) to Include Minimally Invasive Pancreatoduodenectomy: Pan-European Validation. Ann Surg. 2021 Feb 1;273(2):334-340. doi: 10.1097/SLA.0000000000003234.

  PMID: 30829699 RESULT

• Mungroop TH, van Rijssen LB, van Klaveren D, Smits FJ, van Woerden V, Linnemann RJ, de Pastena M, Klompmaker S, Marchegiani G, Ecker BL, van Dieren S, Bonsing B, Busch OR, van Dam RM, Erdmann J, van Eijck CH, Gerhards MF, van Goor H, van der Harst E, de Hingh IH, de Jong KP, Kazemier G, Luyer M, Shamali A, Barbaro S, Armstrong T, Takhar A, Hamady Z, Klaase J, Lips DJ, Molenaar IQ, Nieuwenhuijs VB, Rupert C, van Santvoort HC, Scheepers JJ, van der Schelling GP, Bassi C, Vollmer CM, Steyerberg EW, Abu Hilal M, Groot Koerkamp B, Besselink MG; Dutch Pancreatic Cancer Group. Alternative Fistula Risk Score for Pancreatoduodenectomy (a-FRS): Design and International External Validation. Ann Surg. 2019 May;269(5):937-943. doi: 10.1097/SLA.0000000000002620.

  PMID: 29240007 RESULT

• D'Onofrio M, Tremolada G, De Robertis R, Crosara S, Ciaravino V, Cardobi N, Marchegiani G, Pulvirenti A, Allegrini V, Salvia R, Bassi C, Pozzi Mucelli R. Prevent Pancreatic Fistula after Pancreatoduodenectomy: Possible Role of Ultrasound Elastography. Dig Surg. 2018;35(2):164-170. doi: 10.1159/000477475. Epub 2017 Jun 1.

  PMID: 28564643 RESULT

• Callery MP, Pratt WB, Kent TS, Chaikof EL, Vollmer CM Jr. A prospectively validated clinical risk score accurately predicts pancreatic fistula after pancreatoduodenectomy. J Am Coll Surg. 2013 Jan;216(1):1-14. doi: 10.1016/j.jamcollsurg.2012.09.002. Epub 2012 Nov 2.

  PMID: 23122535 RESULT

• Marchegiani G, Ballarin R, Malleo G, Andrianello S, Allegrini V, Pulvirenti A, Paini M, Secchettin E, Boriero F, Di Benedetto F, Bassi C, Salvia R. Quantitative Assessment of Pancreatic Texture Using a Durometer: A New Tool to Predict the Risk of Developing a Postoperative Fistula. World J Surg. 2017 Nov;41(11):2876-2883. doi: 10.1007/s00268-017-4073-9.

  PMID: 28608016 RESULT

• Wellner UF, Kayser G, Lapshyn H, Sick O, Makowiec F, Hoppner J, Hopt UT, Keck T. A simple scoring system based on clinical factors related to pancreatic texture predicts postoperative pancreatic fistula preoperatively. HPB (Oxford). 2010 Dec;12(10):696-702. doi: 10.1111/j.1477-2574.2010.00239.x.

  PMID: 21083795 RESULT

• Zhong YQ, Zhu XX, Huang XT, Luo YJ, Huang CS, Xu QC, Yin XY. Prediction of clinically relevant postoperative pancreatic fistula after pancreatoduodenectomy based on multifrequency magnetic resonance elastography. J Gastrointest Surg. 2025 Feb;29(2):101886. doi: 10.1016/j.gassur.2024.101886. Epub 2024 Nov 13.

  PMID: 39547592 RESULT

• Sato N, Tamura T, Minagawa N, Hirata K. Preoperative body mass index-to-prognostic nutritional index ratio predicts pancreatic fistula after pancreaticoduodenectomy. Hepatobiliary Surg Nutr. 2016 Jun;5(3):256-62. doi: 10.21037/hbsn.2015.12.08.

  PMID: 27275468 RESULT

• Onodera T, Goseki N, Kosaki G. [Prognostic nutritional index in gastrointestinal surgery of malnourished cancer patients]. Nihon Geka Gakkai Zasshi. 1984 Sep;85(9):1001-5. Japanese.

  PMID: 6438478 RESULT

MeSH Terms

Conditions

Pancreatic Fistula

Interventions

Pancreaticoduodenectomy

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Pancreatic Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Hisham Ali Riad Shaban Ali Riad Hisham Ali Riad Shaban, Professor of General Surgery

CONTACT

01005015757; heshamreyad@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 200 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: October 2, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL