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RecruitingNCT07022015POPFUpdated Nov 10, 2026

Predictive Risk Factors for Pancreatic Fistula After Pancreaticoduodenectomy

An interventional study of pancreaticoduodenectomy procedure in Pancreas Cancer, Pancreas Neoplasm and Pancreatic Fistula, sponsored by Minia University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Minia University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 4 months later.
Updated Nov 10, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 11 studies in Pancreatic Neoplasms by Minia University — 9 open to participants now, 9 under way, 1 of them phase 3. Pancreatic Neoplasms · Minia University.

Started
2025
with 8 others
No phase
5 of 11
5 open now
Registered
4th of 11
by date

Among the 11 studies in Pancreatic Neoplasms by Minia University, this one is one of 9 that started in 2025, is one of 5 with no phase, and was the 4th registered.

By phase

11 studies; the count open now beside each. This study's row is marked.

No phasethis study5 · 5 open
Phase 22 · 2 open
Observational1 · 0 open
Other kind1 · 0 open
Phase 11 · 1 open
Phase 31 · 1 open

By the year they started

First in 2022; this study’s year is marked. 9 started in 2025.

Size and results

Median enrollment 100 across the 9 interventional studies, 91 across the 2 observational. Of the 2 that completed or were terminated, 0 (0%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 11 studies in Pancreatic Neoplasms by Minia University, or all of them as a file.
02

Study summary

Pancreaticoduodenectomy (PD) is a complex procedure performed in patients with malignant or benign tumors of the pancreatic head and periampullary region, associated with high morbidity and mortality. Postoperative pancreatic fistula (POPF) is the most common and clinically significant complication following PD. In this study, the investigators aim to determine the predictive risk factors for clinically related postoperative pancreatic fistula (CR-POPF) in the preoperative, intraoperative and postoperative period in patients that underwent PD. The total number of 100 participants expected to be included in this research who underwent PD between 2025 and 2026.

Read the detailed description

Pancreaticoduodenectomy (PD) is a complex procedure performed in patients with malignant or benign tumors of the pancreatic head and periampullary region, associated with high morbidity and mortality rates. Despite dramatic advancements in surgical techniques and perioperative management, reported morbidity and mortality rates following PD are 41.56% and 2.88%, respectively, which remain unsatisfactory. Postoperative pancreatic fistula (POPF) is the most common and clinically significant complication following PD. Therefore, accurate and timely prediction of POPF after PD is necessary to reduce secondary mortality from serious complications and optimize individual patient treatment decisions. This study aimed to determine the predictive risk factors for clinically related postoperative pancreatic fistula (CR-POPF) in the preoperative, intraoperative and postoperative period in patients that underwent PD.

03

Conditions studied

  • Pancreas Cancer
  • Pancreas Neoplasm
  • Pancreatic Fistula
  • Pancreas Adenocarcinoma
  • Periampullary Cancer
  • Periampullary Carcinoma
  • Resectable Pancreatic Cancer
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with resectable distal common bile duct carcinoma, periampullary carcinoma, duodenal carcinoma, and carcinoma of the head of the pancreas.
  • Patients meeting the curative treatment intent in accordance with clinical guidelines:

    • No evidence of .
    • Radiological non-involvement of superior mesenteric vein \& portal vein.
  • (ASA) scores I \& II.
  • Patients aged > 18 years.
  • Ability to understand and the willingness to sign a written document
  • Agreement to complete the study

Exclusion criteria

Exclusion Criteria:

  • Unfit patients for surgery due to severe medical illness.
  • Inoperable patients with distant , including peritoneal, liver, distant lymph node metastases, and involvement of other organs.
  • Irresectable tumors in diagnostic laparoscopy.
  • History of other malignant disease.
  • Pregnant or breast-feeding women.
  • Patients with serious mental disorders.
  • Patients with vascular invasion and requiring vascular resection as evaluated by the multidisciplinary team according to abdominal imaging data.
  • Pancreatoduodenectomy for other diagnosis like cystic lesions, benign tumors or chronic calcific pancreatitis
  • Patients refused to participate in the study.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    Clinically relevant postoperative pancreatic fistula

    patients who developed clinically relevant postoperative pancreatic fistula after pancreaticoduodenectomy

    Procedure: pancreaticoduodenectomy procedure

Interventions

  • Procedurepancreaticoduodenectomy procedure

    Pancreaticoduodenectomy operation

    Also known as: PD

06

What researchers measure

Primary outcomes

  1. Incidence of clinically relevant post operative pancreatic fistula

    A drainage fluid of any measurable volume with an amylase level more than three times the upper normal serum level on or after the 3rd postoperative day

    Time frame: 10 days

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Sep 20, 2026→Mar 20, 2027
Nov 10, 2026
Study completion
Oct 20, 2026→May 20, 2027
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    Primary completion Sep 20, 2026→Mar 20, 2027
    Study completion Oct 20, 2026→May 20, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07022015
Lead sponsor
Minia University
Responsible party
Saleh Khairy Saleh MD (Lecturer, Minia University) — Principal investigator
First posted
Jun 15, 2025
Start date
Jun 20, 2025
Primary completion
Mar 20, 2027 (estimated)
Completion
May 20, 2027 (estimated)
Last update
Nov 10, 2026

Study contacts

Saleh K Saleh, MD
Contact
salehkhairy@mu.edu.eg
01201765401 ext. +2
Saleh K Saleh, MD
principal investigator · Minia University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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