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Pancreatic Head Resection or Total Pancreatectomy With Islet Autotransplantation in Patients With Periampullary Cancer and High Risk Profile for the Development of Postoperative Pancreatic Fistula

NCT05843877 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-01-30

No results posted yet for this study

Summary

The primary objective of this clinical trial is to evaluate whether primary total pancreatectomy with simultaneous islet autotransplantation compared with pancreatic head resection (alone) can reduce perioperative morbidity and time to initiation of adjuvant therapy in patients with a high-risk constellation for pancreatic fistulas.

Conditions

  • Periampullary Cancer
  • Postoperative Pancreatic Fistula

Interventions

BIOLOGICAL

Intraportal transplantation of isolated autologous pancreatic islets after total pancreatectomy

Islet cells are isolated from patients healthy pancreatic tissue. Following total pancreatectomy, these autologous cells are injected into the portal vein, to implant in the liver and produce insulin.

PROCEDURE

Pancreaticoduodenectomy (classic Whipple or pylorus-preserving)

As a standard procedure, the tumor-affected region of the pancreatic head with surrounding tissue and lymph nodes is removed during surgery. Reconstruction is performed by pancreaticojejunostomy.

Sponsors & Collaborators

  • German Cancer Research Center

    collaborator OTHER

  • Technische Universität Dresden

    lead OTHER

Principal Investigators

  • Barbara Ludwig, Prof. Dr. · Department of internal Medicine III

  • Marius Distler, Prof. Dr. · Department of Visceral, Thoracic and Vascular Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-28
Primary Completion
2028-01-31
Completion
2028-01-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05843877 on ClinicalTrials.gov