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

Status: Recruiting
Location: See location...
Intervention Type: Biological, Procedure
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• suspected or confirmed periampullary carcinoma (tumor) and indication for PPPD (pylorus-preserving pancreaticoduodenectomy) or Whipple surgery

• high-risk profile for the development of a postoperative pancreatic fistula (POPF) after pancreatic head resection: soft pancreas and Pancreatic duct diameter \< 3 mm (preoperative and intraoperative confirmation)

• written informed consent of the participant after successful Informed consent

Locations
Other Locations
Germany
University Hospital Carl Gustav Carus Technische Universität Dresden
RECRUITING
Dresden
Contact Information
Primary
Barbara Ludwig, Prof. Dr.
barbara.ludwig@ukdd.de
+49 458
Time Frame
Start Date: 2025-01-28
Estimated Completion Date: 2028-01
Participants
Target number of participants: 32
Treatments
Experimental: Experimental Therapy
Total pancreatectomy with autologous islet cell transplantation
Other: Standard Therapy
Pancreaticoduodenectomy (classic Whipple or pylorus-preserving)
Sponsors
Leads: Technische Universität Dresden
Collaborators: German Cancer Research Center

This content was sourced from clinicaltrials.gov