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New treatment option for Periampullary Cancer
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
ClinicalTrials.gov ID: NCT05843877
What this study is testing
What is Intraportal transplantation of isolated autologous pancreatic islets after total pancreatectomy?
Intraportal transplantation of isolated autologous pancreatic islets after total pancreatectomy is an investigational medicine, being studied as a potential treatment for periampullary cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- written informed consent of the participant after successful Informed consent
You likely can't join if
- 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
See the full eligibility 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
- 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:
- Post-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea with Serum FSH \> 40 U/ml)
- Post-operative (6 weeks after bilateral ovariectomy with or without hysterectomy)
- Regular and correct use of a contraceptive method with an failure rate \< 1% per year
- Sexual abstinence
- Vasectomy of the partner
- evidence that the patient is unlikely to comply with the protocol
The study team makes the final eligibility decision.
Where it's taking place
- Dresden, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dresden, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.