NCT05843877

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_3

Timeline
21mo left

Started Jan 2025

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Jan 2025Jan 2028

First Submitted

Initial submission to the registry

February 27, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
1.7 years until next milestone

Study Start

First participant enrolled

January 28, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

2.9 years

First QC Date

February 27, 2023

Last Update Submit

January 28, 2026

Conditions

Periampullary CancerPostoperative Pancreatic Fistula

Outcome Measures

Primary Outcomes (1)

  • Duration between surgery and time "fit for adjuvant treatment" (postoperative day X)

    Time (days) between surgery and the date of certified fitness to begin adjuvant therapy, confirmed by an oncology consult, starting at day of discharge, than assessed at POD 90, POD 180, POD 365, 24 months

    From day of discharge until confirmed fitness for adjuvant treatment or 24 months, whichever came first

Secondary Outcomes (16)

  • Comparison of actual start of adjuvant therapy in both arms

    From POD 90 until actual start of therapy or 24 months whichever came first

  • Rate of peri-operative morbidity/mortality acc. to Clavien-Dindo classification

    After enrolment of the patient until 24 months after intervention

  • Rate of (serious) adverse events

    After randomization of the patient until 24 months after intervention

  • Patient reported outcomes: Quality of life EORTC QLQ C30 questionnaire

    From date of screening until 24 months after intervention

  • Patient reported outcomes: Quality of life EORTC PAN26 questionnaire

    From date of screening until 24 months after intervention

  • +11 more secondary outcomes

Study Arms (2)

Experimental Therapy

EXPERIMENTAL

Total pancreatectomy with autologous islet cell transplantation

Biological: Intraportal transplantation of isolated autologous pancreatic islets after total pancreatectomy

Standard Therapy

OTHER

Pancreaticoduodenectomy (classic Whipple or pylorus-preserving)

Procedure: Pancreaticoduodenectomy (classic Whipple or pylorus-preserving)

Interventions

Intraportal transplantation of isolated autologous pancreatic islets after total pancreatectomyBIOLOGICAL

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.

Experimental Therapy
Pancreaticoduodenectomy (classic Whipple or pylorus-preserving)PROCEDURE

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.

Standard Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 diameter \< 3 mm (preoperative and intraoperative confirmation)
  • written informed consent of the participant after successful Informed consent

You may not qualify 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
  • history of hypersensitivity to any of the drugs used or their ingredients or to drugs with a similar chemical structure
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Carl Gustav Carus Technische Universität Dresden

Dresden, Germany

RECRUITING

Related Publications (1)

  • Hempel S, Kolbinger FR, Oehme F, Radulova-Mauersberger O, Schmid J, Schubert U, Schepp F, Bornstein S, Korn S, Trips E, Weitz J, Distler M, Ludwig B. Pancreatoduodenectomy versus total pancreatectomy and simultaneous intraportal islet autotransplantation for periampullary cancer at high-risk of postoperative pancreatic fistula (XANDTX-trial): Protocol of a randomized controlled pilot trial. PLoS One. 2025 Jul 28;20(7):e0327949. doi: 10.1371/journal.pone.0327949. eCollection 2025.

    PMID: 40720532DERIVED

MeSH Terms

Interventions

Pancreaticoduodenectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Barbara Ludwig, Prof. Dr.

    Department of internal Medicine III

    PRINCIPAL INVESTIGATOR

  • Marius Distler, Prof. Dr.

    Department of Visceral, Thoracic and Vascular Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Ludwig, Prof. Dr.

CONTACT

+49 458barbara.ludwig@ukdd.de

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2023

First Posted

May 6, 2023

Study Start

January 28, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)