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Trial 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
NCT ID:
NCT05843877
Condition:
Periampullary Cancer
Postoperative Pancreatic Fistula
Conditions: Official terms:
Pancreatic Fistula
Fistula
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Intraportal transplantation of isolated autologous pancreatic islets after total pancreatectomy
Description:
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.
Arm group label:
Experimental Therapy
Intervention type:
Procedure
Intervention name:
Pancreaticoduodenectomy (classic Whipple or pylorus-preserving)
Description:
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.
Arm group label:
Standard Therapy
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- patients on whom another procedure is to be performed simultaneously in addition to
PPPD or Whipple surgery
- confirmed other primary tumor
- previous transplantation of an organ or tissue
- known infection with HIV (HIV antibodies)
- positive hepatitis C antibodies, positive hepatitis B surface antigens and hepatitis
Bc antibodies
- insulin-treated diabetes mellitus
- history of hypersensitivity to any of the drugs used or their ingredients or to
drugs with a similar chemical structure
- concurrent participation in another clinical trial (incl. within the last 4 weeks
prior to inclusion).
- addiction or other medical conditions that do not allow the subject to understand
the nature and not be able to appreciate the nature, scope and possible consequences
of the trial
- pregnant or breastfeeding women
- women of childbearing age, except for women who meet the following criteria:
1. Post-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea with
Serum FSH > 40 U/ml)
2. Post-operative (6 weeks after bilateral ovariectomy with or without
hysterectomy)
3. Regular and correct use of a contraceptive method with an failure rate < 1% per
year
4. Sexual abstinence
5. Vasectomy of the partner
- evidence that the patient is unlikely to comply with the protocol
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital Carl Gustav Carus Technische Universität Dresden
Address:
City:
Dresden
Country:
Germany
Start date:
October 2024
Completion date:
January 2028
Lead sponsor:
Agency:
Technische Universität Dresden
Agency class:
Other
Collaborator:
Agency:
KKS Dresden
Agency class:
Other
Collaborator:
Agency:
German Cancer Research Center
Agency class:
Other
Source:
Technische Universität Dresden
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05843877
