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 - Clinical Trial for Periampullary Cancer | NCT05843877

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Primary Purpose

Status

Not yet recruiting

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Intraportal transplantation of isolated autologous pancreatic islets after total pancreatectomy

Pancreaticoduodenectomy (classic Whipple or pylorus-preserving)

About this trial

This is an interventional treatment trial for Periampullary Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 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

Sites / Locations

University Hospital Carl Gustav Carus Technische Universität Dresden

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental Therapy

Standard Therapy

Arm Description

Total pancreatectomy with autologous islet cell transplantation

Pancreaticoduodenectomy (classic Whipple or pylorus-preserving)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Comparison of actual start of adjuvant therapy in both arms

Postoperative day on which adjuvant therapy was started

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

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)

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

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).

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

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

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

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

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

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

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

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

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

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

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

Full Information

NCT ID

NCT05843877

First Posted

February 27, 2023

Last Updated

September 4, 2023

Sponsor

Technische Universität Dresden

Collaborators

KKS Dresden, German Cancer Research Center

1. Study Identification

Unique Protocol Identification Number

NCT05843877

Brief Title

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

Acronym

XandTX

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)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 2023 (Anticipated)

Primary Completion Date

January 2028 (Anticipated)

Study Completion Date

January 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Technische Universität Dresden

Collaborators

KKS Dresden, German Cancer Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periampullary Cancer, Postoperative Pancreatic Fistula

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental Therapy

Arm Type

Experimental

Arm Description

Total pancreatectomy with autologous islet cell transplantation

Arm Title

Standard Therapy

Arm Type

Other

Arm Description

Pancreaticoduodenectomy (classic Whipple or pylorus-preserving)

Intervention Type

Biological

Intervention Name(s)

Intraportal transplantation of isolated autologous pancreatic islets after total pancreatectomy

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Pancreaticoduodenectomy (classic Whipple or pylorus-preserving)

Intervention Description

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 Outcome Measure Information:

Title

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

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Comparison of actual start of adjuvant therapy in both arms

Description

Postoperative day on which adjuvant therapy was started

Time Frame

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

Title

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

Description

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

Time Frame

After enrolment of the patient until 24 months after intervention

Title

Rate of (serious) adverse events

Description

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

Time Frame

After randomization of the patient until 24 months after intervention

Title

Patient reported outcomes: Quality of life EORTC QLQ C30 questionnaire

Description

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

Time Frame