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NCT Number: NCT05843877

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

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.

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Key information

Conditions

Periampullary Cancer Postoperative Pancreatic Fistula

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital Carl Gustav Carus Technische Universität Dresden

Dresden, Germany

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

Treatment and study plan

Intraportal transplantation of isolated autologous pancreatic islets after total pancreatectomy

Biological

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.

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.

Primary outcomes

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

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

    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

Secondary outcomes

  1. Comparison of actual start of adjuvant therapy in both arms

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

    Postoperative day on which adjuvant therapy was started

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

    Time frame: After enrolment of the patient until 24 months after intervention

    Rate of peri-operative morbidity/mortality will be assessed acc. to Clavien-Dindo classification

  3. Rate of (serious) adverse events

    Time frame: After randomization of the patient until 24 months after intervention

    Rate of (serious) adverse events, according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0, 2017)

  4. Patient reported outcomes: Quality of life EORTC QLQ C30 questionnaire

    Time frame: From date of screening until 24 months after intervention

    The QoL analyses will include QoL mean values, QoL response. EORTC QLQ C30 contains 30 questions28 questions regarding body fitness, daily routines, restrictions at work and hobby, appetite, fatigue, cough, breathlessness, pain, tiredness, and body conditions from (1) to (4); 1 (not a bit), 2 (little), 3 (moderate), 4 (much).

    2 questions regarding state of health and Quality of life with a horizontal rating from 1 to 7; 1 (very bad), 7 (excellent).; assessed at POD 90, POD 180, POD 365, and 24 months after surgery

  5. Patient reported outcomes: Quality of life EORTC PAN26 questionnaire

    Time frame: From date of screening until 24 months after intervention

    The QoL analyses will include QoL mean values, QoL response. EORTC QLQ PAN26 contains 30 questions regarding pain, nutrition, body fitness, sexuality, from (1) to (4); 1 (not a bit), 2 (little), 3 (moderate), 4 (much).

    28 questions regarding body fitness, daily routines, restrictions at work and hobby, appetite, fatigue, cough, breathlessness, pain, tiredness, and body conditions from (1) to (4); 1 (not a bit), 2 (little), 3 (moderate), 4 (much); , assessed at POD 90, POD 180, POD 365, and 24 months after surgery

    2 questions regarding state of health and Quality of life with a horizontal rating from 1 to 7; 1 (very bad), 7 (excellent).

  6. Comparison of metabolic outcome in both arms: continuous glucose monitoring (CGM)

    Time frame: From date of screening until 24 months after intervention

    Metabolic outcome will be determined on continuous monitoring of glucose (CGM) in plasma (mmol/L) at every visit: Screening, POD 1, POD 3, day of discharge, POD 90, POD 180, POD 365 and 24 months after intervention

  7. Comparison of metabolic outcome in both arms: glucagon

    Time frame: From date of screening until 24 months after intervention

    Metabolic outcome will be determined on the hormone glucagon in plasma at every visit: Screening, POD 1, POD 3, day of discharge, POD 90, POD 180, POD 365 and 24 months after intervention

  8. Comparison of metabolic outcome in both arms: glycohemoglobin HbA1c

    Time frame: From date of screening until 24 months after intervention

    Metabolic outcome will be determined on glycohemoglobin (HbA1c in %) at every visit: Screening, POD 1, POD 3, day of discharge, POD 90, POD 180, POD 365 and 24 months after intervention

  9. Comparison of metabolic outcome in both arms: C-peptide

    Time frame: From date of screening until 24 months after intervention

    Metabolic outcome will be determined on serum C-peptide (nmol/L) as measure for functionality of pancreas at every visit: Screening, POD 1, POD 3, day of discharge, POD 90, POD 180, POD 365 and 24 months after intervention

  10. Comparison of metabolic outcome in both arms: fructosamine

    Time frame: From date of screening until 24 months after intervention

    Metabolic outcome will be determined on serum fructosamine (µmol/L) at every visit: Screening, POD 1, POD 3, day of discharge, POD 90, POD 180, POD 365 and 24 months after intervention

  11. Comparison of metabolic outcome in both arms: insulin requirement

    Time frame: From date of screening until 24 months after intervention

    Metabolic outcome will be determined on requirement of insulin (yes/no) at every visit: Screening, POD 1, POD 3, day of discharge, POD 90, POD 180, POD 365 and 24 months after intervention

  12. Comparison of metabolic outcome in both arms: number of hypoglycemic events

    Time frame: From date of screening until 24 months after intervention

    Metabolic outcome will be determined on number of hypoglycemic events (defined as value of blood glucose below 3.5 mmol/l) at every visit: Screening, POD 1, POD 3, day of discharge, POD 90, POD 180, POD 365 and 24 months after intervention

  13. Comparison of metabolic outcome in both arms: severity of hypoglycemia

    Time frame: From date of screening until 24 months after intervention

    Metabolic outcome will be determined on severity of hypoglycemic events (decrease of blood glucose level) at every visit: Screening, POD 1, POD 3, day of discharge, POD 90, POD 180, POD 365 and 24 months after intervention

  14. Comparison of long-term oncological course (24 months) in both arms: tumor markers

    Time frame: 24 months after intervention

    Within 24 months after intervention, oncological outcome is evaluated, as measured by tumor markers CA 19-9, CEA

  15. Comparison of long-term oncological course (24 months) in both arms: recurrence

    Time frame: 24 months after intervention

    Within 24 months after intervention, oncological outcome is evaluated, as measured by recurrences of tumor shown in CT imaging

  16. Comparison of long-term oncological course (24 months) in both arms: occurence of metastases

    Time frame: 24 months after intervention

    Within 24 months after intervention, oncological outcome is evaluated, as measured by metastases shown in CT imaging

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara Ludwig, Prof. Dr.

CONTACT

[email protected]

+49 458

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

  • German Cancer Research Center

Registry information

Official study title

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)

Acronym: XandTX

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 6, 2023
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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