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
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
Overall status: RECRUITING
Phase: PHASE3
Conditions: Periampullary Cancer
Postoperative Pancreatic Fistula
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: German Cancer Research Center
First posted: 2023-05-06
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Duration between surgery and time "fit for adjuvant treatment" (postoperative day X)
timeFrame: From day of discharge until confirmed fitness for adjuvant treatment or 24 months, whichever came first
Secondary outcomes:
measure: Comparison of actual start of adjuvant therapy in both arms
timeFrame: From POD 90 until actual start of therapy or 24 months whichever came first
measure: Rate of peri-operative morbidity/mortality acc. to Clavien-Dindo classification
timeFrame: After enrolment of the patient until 24 months after intervention
measure: Rate of (serious) adverse events
timeFrame: After randomization of the patient until 24 months after intervention
measure: Patient reported outcomes: Quality of life EORTC QLQ C30 questionnaire
timeFrame: From date of screening until 24 months after intervention
measure: Patient reported outcomes: Quality of life EORTC PAN26 questionnaire
timeFrame: From date of screening until 24 months after intervention
measure: Comparison of metabolic outcome in both arms: continuous glucose monitoring (CGM)
timeFrame: From date of screening until 24 months after intervention
measure: Comparison of metabolic outcome in both arms: glucagon
timeFrame: From date of screening until 24 months after intervention
measure: Comparison of metabolic outcome in both arms: glycohemoglobin HbA1c
timeFrame: From date of screening until 24 months after intervention
measure: Comparison of metabolic outcome in both arms: C-peptide
timeFrame: From date of screening until 24 months after intervention
measure: Comparison of metabolic outcome in both arms: fructosamine
timeFrame: From date of screening until 24 months after intervention
measure: Comparison of metabolic outcome in both arms: insulin requirement
timeFrame: From date of screening until 24 months after intervention
measure: Comparison of metabolic outcome in both arms: number of hypoglycemic events
timeFrame: From date of screening until 24 months after intervention
measure: Comparison of metabolic outcome in both arms: severity of hypoglycemia
timeFrame: From date of screening until 24 months after intervention
measure: Comparison of long-term oncological course (24 months) in both arms: tumor markers
timeFrame: 24 months after intervention
measure: Comparison of long-term oncological course (24 months) in both arms: recurrence
timeFrame: 24 months after intervention
measure: Comparison of long-term oncological course (24 months) in both arms: occurence of metastases
timeFrame: 24 months after intervention
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus Technische Universität Dresden
Study officials:
affiliation: Department of internal Medicine III
name: Barbara Ludwig, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Visceral, Thoracic and Vascular Surgery
name: Marius Distler, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: