Partial or total removal of the pancreas and transplantation of the patient's own islet cells in patients with pancreatic cancer and a high risk to develop fistulas (leaks) after surgery

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Technische Universitat Dresden

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Neoplasms [C04]

Trial duration

11 Dec 2024 → ongoing

Decision date (initial)

2024-04-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Deutsches Krebsforschungszentrum (DKFZ)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

To obtain first data on the treatment effect of primary total pancreatectomy with simultaneous autologous islet transplantation in patients with periampullary carcinoma and high-risk profile for the development of postoperative pancreatic fistulae (POPF).

Secondary objectives 6

1. To determine the safety of the procedure
2. To determine the perioperative mortality and morbidity
3. To assess the life quality
4. To determine the metabolic outcome
5. To assess the oncological long term course
6. To determine the duration until the actual start of the adjuvant therapy

Conditions and MedDRA coding

Patients with perampullary carcinoma and a high-risk profile to develop postoperative pancreatic fistulas

Study design 3 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Male and female patients ≥18 years
2. Suspicion of or confirmed diagnosis of periampullary cancer and indication for pylorus preserving pancreaticoduodenectomy (PPPD) or Whipple surgery
3. High risk profile for the development of a postoperative pancreatic fistula (POPF) after pancreatic head resection: soft pancreatic tissue and a pancreatic duct diameter <3mm (pre- and intraoperative confirmation)
4. Written informed consent after clarification

Exclusion criteria 14

1. Patients planned for an additional surgery besides the PPD or Whipple surgery
2. Diagnosis of a second primary cancer
3. Previous organ- or tissue transplant
4. Known HIV infection (HIV antibody test)
5. Positivity for Anti-HCV, positive anti-HBsAg or anti-HBc
6. Insulin treated diabetes
7. Known hypersensitivity towards one of the substances under investigation or its components or substances of similar chemical structure
8. Individuals, who are dependent from the sponsor
9. Individuals of vulnerable groups, such as: a) Adults, who are unable to understand the nature, significance and scope of the clinical trial and who are unable to articulate their will accordingly; b)Individuals, who are unable to give consent; c) Individuals, who are institutionalized by court or official order ; d) Individuals listed under exclusion criteria 12 as well as inclusion criteria 1 and 4
10. Simultaneous participation in another interventional clinical trial (up to 4 weeks before enrolment)
11. Addiction or other concomitant diseases, which prevent the participant from understanding and comprehending the scope, nature and potential consequences of the clinical trial
12. Pregnant or lactating women
13. Women of childbearing potential, except for women who meet at least one of the following criteria: a) Postmenopausal; b) Post-surgery (6 weeks after bilateral ovariectomy, bilateral salpingectomy with or without a hysterectomy); c) Negative pregnancy test (serum) and the willingness to regularly and correctly use a highly effective contraceptive method (Pearl Index <1%); d) Abstinence; e) Partner’s vasectomy
14. Any indication that the participant is unlikely to adhere to the protocol (i.e. lack of compliance)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Duration between surgery and the date of the decision "fit for adjuvant treatment" (postoperative day X)

Secondary endpoints 6

1. Duration between surgery and the actual start of adjuvant therapy
2. Perioperative morbidity and mortality
3. Number and type of adverse events and serious adverse events
4. Quality of life (post-surgery, EORTC QLQ-C30/Pan26)
5. Metabolic outcome
6. Oncological long term course (60 months)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Technische Universitat Dresden

Sponsor organisation

Technische Universitat Dresden

Address

Mommsenstrasse 11, Raecknitz/zschertnitz Raecknitz/zschertnitz

City

Dresden

Postcode

01069

Country

Germany

Scientific contact point

Organisation

Technische Universitat Dresden

Contact name

Prof. Dr. med. Barbara Ludwig

Public contact point

Organisation

Technische Universitat Dresden

Contact name

Prof. Dr. med. Barbara Ludwig

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications