RecruitingPhase 3NCT05843877

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

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)

Sponsor

Technische Universität Dresden

Enrollment

32 participants

Start Date

Jan 28, 2025

Study Type

INTERVENTIONAL

Conditions

Periampullary Cancer Postoperative Pancreatic Fistula

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares standard Whipple surgery (removing the head of the pancreas) versus a modified version that also includes islet cell autotransplantation — where the patient's own insulin-producing cells are rescued and transplanted into the liver to prevent or reduce diabetes after surgery. It focuses on patients at high risk of complications from pancreatic fluid leakage after surgery. **You may be eligible if...** - You have a suspected or confirmed tumor near the head of the pancreas (periampullary carcinoma) requiring a Whipple procedure - Your pancreas is soft and your pancreatic duct is narrow (less than 3 mm), which increases the risk of fluid leakage after surgery **You may NOT be eligible if...** - You need a different surgical procedure performed at the same time as pancreatic surgery - Your cancer is confirmed to have spread widely (metastatic) - You have severe diabetes or conditions that make islet cell transplantation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALIntraportal 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.

PROCEDUREPancreaticoduodenectomy (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.