Periampullary CancerPhase 3XandTXNCT05843877
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
A Phase 3 study testing Intraportal transplantation of isolated autologous pancreatic islets after total pancreatectomy and Pancreaticoduodenectomy (classic Whipple or pylorus-preserving) in people with Periampullary Cancer and Postoperative Pancreatic Fistula, run by Technische Universität Dresden at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periampullary Cancer, Postoperative Pancreatic Fistula
- What is being tested?
- Intraportal transplantation of isolated autologous pancreatic islets after total pancreatectomy and Pancreaticoduodenectomy (classic Whipple or pylorus-preserving)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- 28 Jan 2025to Jan 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Carl Gustav Carus Technische Universität Dresden
Dresden
About this study
Official 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)
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.
- Being tested
- Intraportal transplantation of isolated autologous pancreatic islets after total pancreatectomy, Pancreaticoduodenectomy (classic Whipple or pylorus-preserving)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Pancreaticoduodenectomy (classic Whipple or pylorus-preserving)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Therapy | Experimental | Total pancreatectomy with autologous islet cell transplantation Receives: Biological: Intraportal transplantation of isolated autologous pancreatic islets after total pancreatectomy |
| Standard Therapy | Other | Pancreaticoduodenectomy (classic Whipple or pylorus-preserving) Receives: Procedure: Pancreaticoduodenectomy (classic Whipple or pylorus-preserving) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Postoperative day on which adjuvant therapy was started
Measured: 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
Rate of peri-operative morbidity/mortality will be assessed acc. to Clavien-Dindo classification
Measured: After enrolment of the patient until 24 months after intervention
Rate of (serious) adverse events
Rate of (serious) adverse events, according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0, 2017)
Measured: After randomization of the patient until 24 months after intervention
Patient reported outcomes: Quality of life EORTC QLQ C30 questionnaire
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
Measured: From date of screening until 24 months after intervention
Patient reported outcomes: Quality of life EORTC PAN26 questionnaire
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).
Measured: From date of screening until 24 months after intervention
Comparison of metabolic outcome in both arms: continuous glucose monitoring (CGM)
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
Measured: From date of screening until 24 months after intervention
Comparison of metabolic outcome in both arms: glucagon
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
Measured: From date of screening until 24 months after intervention
Comparison of metabolic outcome in both arms: glycohemoglobin HbA1c
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
Measured: From date of screening until 24 months after intervention
Comparison of metabolic outcome in both arms: C-peptide
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
Measured: From date of screening until 24 months after intervention
Comparison of metabolic outcome in both arms: fructosamine
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
Measured: From date of screening until 24 months after intervention
Comparison of metabolic outcome in both arms: insulin requirement
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
Measured: From date of screening until 24 months after intervention
Comparison of metabolic outcome in both arms: number of hypoglycemic events
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
Measured: From date of screening until 24 months after intervention
Comparison of metabolic outcome in both arms: severity of hypoglycemia
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
Measured: From date of screening until 24 months after intervention
Comparison of long-term oncological course (24 months) in both arms: tumor markers
Within 24 months after intervention, oncological outcome is evaluated, as measured by tumor markers CA 19-9, CEA
Measured: 24 months after intervention
Comparison of long-term oncological course (24 months) in both arms: recurrence
Within 24 months after intervention, oncological outcome is evaluated, as measured by recurrences of tumor shown in CT imaging
Measured: 24 months after intervention
Comparison of long-term oncological course (24 months) in both arms: occurence of metastases
Within 24 months after intervention, oncological outcome is evaluated, as measured by metastases shown in CT imaging
Measured: 24 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start28 Jan 2025
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periampullary CancerStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- German Cancer Research Center
- Responsible party
- Sponsor
- Investigators
- Barbara Ludwig, Prof. Dr., Principal investigator, Department of internal Medicine IIIMarius Distler, Prof. Dr., Principal investigator, Department of Visceral, Thoracic and Vascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843877
- Sponsor's protocol ID
- TUD-XandTX-079
- Other IDs
- 2023-507773-17-00, 2023
- Acronym
- XandTX
- Status last verified
- Jan 2026
- First submitted
- 27 Feb 2023
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40720532
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT05843877
- Acronym / sponsor ID
- XandTX / TUD-XandTX-079
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- German Cancer Research Center
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Therapy | Experimental | Biological: Intraportal transplantation of isolated autologous pancreatic islets after total pancreatectomyTotal pancreatectomy with autologous islet cell transplantation |
| Standard Therapy | Other | Procedure: Pancreaticoduodenectomy (classic Whipple or pylorus-preserving)Pancreaticoduodenectomy (classic Whipple or pylorus-preserving) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraportal transplantation of isolated autologous pancreatic islets after total pancreatectomyIslet 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. | Biological | Experimental Therapy |
| Pancreaticoduodenectomy (classic Whipple or pylorus-preserving)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. | Procedure or surgery | Standard Therapy |
Primary outcome
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
16 secondary outcomes
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
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 (serious) adverse events
Time frame: After randomization of the patient until 24 months after intervention
Patient reported outcomes: Quality of life EORTC QLQ C30 questionnaire
Time frame: From date of screening until 24 months after intervention
Patient reported outcomes: Quality of life EORTC PAN26 questionnaire
Time frame: From date of screening until 24 months after intervention
Comparison of metabolic outcome in both arms: continuous glucose monitoring (CGM)
Time frame: From date of screening until 24 months after intervention
Comparison of metabolic outcome in both arms: glucagon
Time frame: From date of screening until 24 months after intervention
Comparison of metabolic outcome in both arms: glycohemoglobin HbA1c
Time frame: From date of screening until 24 months after intervention
Comparison of metabolic outcome in both arms: C-peptide
Time frame: From date of screening until 24 months after intervention
Comparison of metabolic outcome in both arms: fructosamine
Time frame: From date of screening until 24 months after intervention
Comparison of metabolic outcome in both arms: insulin requirement
Time frame: From date of screening until 24 months after intervention
Comparison of metabolic outcome in both arms: number of hypoglycemic events
Time frame: From date of screening until 24 months after intervention
Comparison of metabolic outcome in both arms: severity of hypoglycemia
Time frame: From date of screening until 24 months after intervention
Comparison of long-term oncological course (24 months) in both arms: tumor markers
Time frame: 24 months after intervention
Comparison of long-term oncological course (24 months) in both arms: recurrence
Time frame: 24 months after intervention
Comparison of long-term oncological course (24 months) in both arms: occurence of metastases
Time frame: 24 months after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Derived from this study: PubMed 40720532Hempel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Barbara Ludwig, Prof. Dr. principal investigator
Department of internal Medicine III
Marius Distler, Prof. Dr. principal investigator
Department of Visceral, Thoracic and Vascular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intraportal transplantation of isolated autologous pancreatic islets after total pancreatectomy and Pancreaticoduodenectomy (classic Whipple or pylorus-preserving) in people with Periampullary Cancer and Postoperative Pancreatic Fistula, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbara Ludwig, Prof. Dr. (+49 458, barbara.ludwig@ukdd.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05843877, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.