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RECRUITINGPHASE3

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)

NCT05843877•Technische Universität Dresden

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+7 more criteria

Locations (1)

University Hospital Carl Gustav Carus Technische Universität Dresden

Dresden, Germany

Key Dates

Start Date

January 28, 2025

Primary Completion Date

January 1, 2028

Completion Date

January 1, 2028

Last Updated

January 30, 2026

Enrollment

ESTIMATED participants

Conditions

Periampullary CancerPostoperative Pancreatic Fistula

Interventions

Intraportal transplantation of isolated autologous pancreatic islets after total pancreatectomy

BIOLOGICAL

Pancreaticoduodenectomy (classic Whipple or pylorus-preserving)

PROCEDURE

Contacts

Barbara Ludwig, Prof. Dr.

CONTACT

+49 458 barbara.ludwig@ukdd.de

Prehabilitation in Pancreatic Surgery

NCT06069297

Pancreatic CancerPeriampullary Cancer+3 more

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RECRUITING

Association Between Perioperative Blood and Interstitial Fluid Glucose Level and Clinically Relevant Postoperative Pancreatic Fistula in Different Pancreatic Surgeries

NCT06289530

Postoperative Pancreatic Fistula

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Prehabilitation in Pancreatic Surgery

Association Between Perioperative Blood and Interstitial Fluid Glucose Level and Clinically Relevant Postoperative Pancreatic Fistula in Different Pancreatic Surgeries

Intrapapillary Botulinum Toxin Injection for PREvention of Post-surgical PAncREactic Fistula

PAN-ICIS Study: ICIS for Early Detection of Infectious Complications in Pancreatic Surgery

The Novel Modified Cattell-Warren Duct-To-Mucosa Pancreaticojejunostomy Technique Significantly Reduces POPF.

Prophylactic Abdominal Drainage vs no Drainage After Distal Pancreatectomy