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 3RecruitingNCT05843877

Technische Universität Dresden32 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Periampullary Cancer Postoperative Pancreatic Fistula

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

Comparison of actual start of adjuvant therapy in both arms

Postoperative day on which adjuvant therapy was started

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

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

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)

Time frame: 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