Actively Recruiting
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
Led by Technische Universität Dresden · Updated on 2026-01-30
32
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
Sponsors
T
Technische Universität Dresden
Lead Sponsor
G
German Cancer Research Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Suspected or confirmed periampullary carcinoma and eligible for pylorus-preserving pancreaticoduodenectomy (PPPD) or Whipple surgery
- High-risk profile for postoperative pancreatic fistula with soft pancreas and pancreatic duct diameter less than 3 mm confirmed before and during surgery
- Provided written informed consent after being informed about the study
You will not qualify if you...
- Undergoing additional procedures beyond PPPD or Whipple surgery
- Presence of another confirmed primary tumor
- Previous organ or tissue transplantation
- Known HIV infection
- Positive hepatitis C antibodies or positive hepatitis B surface antigens and hepatitis Bc antibodies
- Insulin-treated diabetes mellitus
- History of allergic reactions to study drugs or similar drugs
- Participation in another clinical trial within 4 weeks prior to enrollment
- Addiction or medical conditions preventing understanding of the trial
- Pregnant or breastfeeding women
- Women of childbearing age not meeting specific criteria such as post-menopause, post-operative ovariectomy, correct contraceptive use, sexual abstinence, or partner vasectomy
- Evidence suggesting inability to comply with study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospital Carl Gustav Carus Technische Universität Dresden
Dresden, Germany
Actively Recruiting
Research Team
B
Barbara Ludwig, Prof. Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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