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

Phase 3

Recruiting

Conditions: Postoperative Pancreatic Fistula
Periampullary Cancer

Interventions: Procedure: Pancreaticoduodenectomy (classic Whipple or pylorus-preserving)
Biological: Intraportal transplantation of isolated autologous pancreatic islets after total pancreatectomy

Registration Number: NCT05843877

Lead Sponsor: Technische Universität Dresden

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: RECRUITING

Sex: All

Target Recruitment: 32

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:
1. Post-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea with Serum FSH > 40 U/ml)
2. Post-operative (6 weeks after bilateral ovariectomy with or without hysterectomy)
3. Regular and correct use of a contraceptive method with an failure rate < 1% per year
4. Sexual abstinence
5. Vasectomy of the partner
evidence that the patient is unlikely to comply with the protocol

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Therapy	Pancreaticoduodenectomy (classic Whipple or pylorus-preserving)	Pancreaticoduodenectomy (classic Whipple or pylorus-preserving)
Experimental Therapy	Intraportal transplantation of isolated autologous pancreatic islets after total pancreatectomy	Total pancreatectomy with autologous islet cell transplantation

Primary Outcome Measures

Name	Time	Method
Duration between surgery and time "fit for adjuvant treatment" (postoperative day X)	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 Outcome Measures

Name	Time	Method
Rate of peri-operative morbidity/mortality acc. to Clavien-Dindo classification	After enrolment of the patient until 24 months after intervention	Rate of peri-operative morbidity/mortality will be assessed acc. to Clavien-Dindo classification
Comparison of actual start of adjuvant therapy in both arms	From POD 90 until actual start of therapy or 24 months whichever came first	Postoperative day on which adjuvant therapy was started
Rate of (serious) adverse events	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)
Patient reported outcomes: Quality of life EORTC QLQ C30 questionnaire	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
Patient reported outcomes: Quality of life EORTC PAN26 questionnaire	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).
Comparison of metabolic outcome in both arms: glucagon	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
Comparison of metabolic outcome in both arms: glycohemoglobin HbA1c	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
Comparison of metabolic outcome in both arms: continuous glucose monitoring (CGM)	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
Comparison of metabolic outcome in both arms: fructosamine	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
Comparison of metabolic outcome in both arms: number of hypoglycemic events	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
Comparison of metabolic outcome in both arms: severity of hypoglycemia	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
Comparison of long-term oncological course (24 months) in both arms: recurrence	24 months after intervention	Within 24 months after intervention, oncological outcome is evaluated, as measured by recurrences of tumor shown in CT imaging
Comparison of metabolic outcome in both arms: C-peptide	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
Comparison of metabolic outcome in both arms: insulin requirement	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
Comparison of long-term oncological course (24 months) in both arms: tumor markers	24 months after intervention	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: occurence of metastases	24 months after intervention	Within 24 months after intervention, oncological outcome is evaluated, as measured by metastases shown in CT imaging

Trial Locations

Locations (1): University Hospital Carl Gustav Carus Technische Universität Dresden
🇩🇪
Dresden, Germany

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

Recruitment & Eligibility

Study & Design

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