- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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 (XandTX)
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)
Study Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Barbara Ludwig, Prof. Dr.
- Phone Number: +49 458
- Email: barbara.ludwig@ukdd.de
Study Locations
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Dresden, Germany
- University Hospital Carl Gustav Carus Technische Universität Dresden
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Therapy
Total pancreatectomy with autologous islet cell transplantation
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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.
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Other: Standard Therapy
Pancreaticoduodenectomy (classic Whipple or pylorus-preserving)
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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
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From day of discharge until confirmed fitness for adjuvant treatment or 24 months, whichever came first
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Postoperative day on which adjuvant therapy was started
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From POD 90 until actual start of therapy or 24 months whichever came first
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Rate of peri-operative morbidity/mortality acc. to Clavien-Dindo classification
Time Frame: After enrolment of the patient until 24 months after intervention
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Rate of peri-operative morbidity/mortality will be assessed acc. to Clavien-Dindo classification
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After enrolment of the patient until 24 months after intervention
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Rate of (serious) adverse events
Time Frame: After randomization of the patient until 24 months after intervention
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Rate of (serious) adverse events, according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0, 2017)
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After randomization of the patient until 24 months after intervention
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Patient reported outcomes: Quality of life EORTC QLQ C30 questionnaire
Time Frame: From date of screening until 24 months after intervention
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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 |
From date of screening until 24 months after intervention
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Patient reported outcomes: Quality of life EORTC PAN26 questionnaire
Time Frame: From date of screening until 24 months after intervention
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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). |
From date of screening until 24 months after intervention
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Comparison of metabolic outcome in both arms: continuous glucose monitoring (CGM)
Time Frame: From date of screening until 24 months after intervention
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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
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From date of screening until 24 months after intervention
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Comparison of metabolic outcome in both arms: glucagon
Time Frame: From date of screening until 24 months after intervention
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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
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From date of screening until 24 months after intervention
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Comparison of metabolic outcome in both arms: glycohemoglobin HbA1c
Time Frame: From date of screening until 24 months after intervention
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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
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From date of screening until 24 months after intervention
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Comparison of metabolic outcome in both arms: C-peptide
Time Frame: From date of screening until 24 months after intervention
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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
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From date of screening until 24 months after intervention
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Comparison of metabolic outcome in both arms: fructosamine
Time Frame: From date of screening until 24 months after intervention
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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
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From date of screening until 24 months after intervention
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Comparison of metabolic outcome in both arms: insulin requirement
Time Frame: From date of screening until 24 months after intervention
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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
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From date of screening until 24 months after intervention
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Comparison of metabolic outcome in both arms: number of hypoglycemic events
Time Frame: From date of screening until 24 months after intervention
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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
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From date of screening until 24 months after intervention
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Comparison of metabolic outcome in both arms: severity of hypoglycemia
Time Frame: From date of screening until 24 months after intervention
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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
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From date of screening until 24 months after intervention
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Comparison of long-term oncological course (24 months) in both arms: tumor markers
Time Frame: 24 months after intervention
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Within 24 months after intervention, oncological outcome is evaluated, as measured by tumor markers CA 19-9, CEA
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24 months after intervention
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Comparison of long-term oncological course (24 months) in both arms: recurrence
Time Frame: 24 months after intervention
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Within 24 months after intervention, oncological outcome is evaluated, as measured by recurrences of tumor shown in CT imaging
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24 months after intervention
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Comparison of long-term oncological course (24 months) in both arms: occurence of metastases
Time Frame: 24 months after intervention
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Within 24 months after intervention, oncological outcome is evaluated, as measured by metastases shown in CT imaging
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24 months after intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Barbara Ludwig, Prof. Dr., Department of internal Medicine III
- Principal Investigator: Marius Distler, Prof. Dr., Department of Visceral, Thoracic and Vascular Surgery
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TUD-XandTX-079
- 2021-002466-40 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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