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Tests treatment safety and results for Adenocarcinoma of the Pancreas
Official title Efficacy and Safety of TPIAT for Resectable Adenocarcinoma of the Pancreas Region at High Risk of Postoperative Fistula
ClinicalTrials.gov ID: NCT05116072
What this study is testing
What is intraportal islet autotransplantation?
intraportal islet autotransplantation is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for adenocarcinoma of the pancreas.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Curative management of locally resectable invasive adenocarcinomas located in the cephalic region of the pancreas (pancreas, duodenum and ampulla of Vater) requires a pancreaticoduodenectomy followed by adjuvant chemotherapy. Pancreaticoduodenectomy is a major surgery that often leads to major complications including approximately 20% of relevant clinical postoperative pancreatic fistula.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- are composed of preoperative conditions validated by intraoperative confirmation to plan an exit of the protocol if the pancreas does not finally...
- Age ≥ 18 years
- Locale resectable invasive adenocarcinomas located in the cephalic region of the pancreas documented by endoscopic ultrasonography with fine-needle...
- pancreatic adenocarcinoma;
- duodenal adenocarcinoma;
You likely can't join if
- Patient will be screened and excluded if they present a preoperative diabetes defined by a stimulated C-peptide \ 2 g/dL, at 2 hours in post prandial
- Patients with a known or highly suspected genetic syndrome associated with a risk of pancreatic adenocarcinoma: familial pancreatic cancer, multiple...
- Multifocal pancreatic adenocarcinomas identified during preoperative evaluation;
- Performance status and comorbidity profile inappropriate for a major abdominal surgery;
- Contraindication for autologous islet intraportal transplantation
- Current or indicated/scheduled neoadjuvant chemotherapy;
See the full eligibility criteria
- are composed of preoperative conditions validated by intraoperative confirmation to plan an exit of the protocol if the pancreas does not finally appear with a high-risk of CR-POPF.
- Age ≥ 18 years
- Locale resectable invasive adenocarcinomas located in the cephalic region of the pancreas documented by endoscopic ultrasonography with fine-needle aspiration biopsy
- pancreatic adenocarcinoma;
- duodenal adenocarcinoma;
- ampullary adenocarcinoma;
- and IPMNs with adenocarcinoma degeneration;
- A potentially curative strategy with primary tumor resection approved by a multidisciplinary expert team
- A high-risk of CR-POPF
- Suspected during preoperative evaluation by the presence of 2 or more of the following criteria (screening criteria of inclusion) : sex male;an obesity (BMI ≥ 30 kg/m2);a main pancreatic duct diameter ≤ 3 mm on...
- and validated during intraoperative evaluation (finale inclusion) by a probability score above or equal to 20% on the validated updated alternative Fistula Risk Score ua-FRS for pancreaticoduodenectomy (ua-FRS) based of...
- Women of childbearing potential should only be included after a confirmed menstrual period, and a negative highly sensitive urine or serum pregnancy test and must agree to be subjected to a monthly pregnancy test (urine...
- Women of child-bearing potential and male people must agree to use a birth control methods which may be considered as highly effective (failure rate of less than 1% per year ) as recommended by the CTFG (Cinical Trials...
- Patient covered by a health insurance system
- Patient who provides a written informed consent to participate to the study
- Patient will be screened and excluded if they present a preoperative diabetes defined by a stimulated C-peptide \ 2 g/dL, at 2 hours in post prandial
- Patients with a known or highly suspected genetic syndrome associated with a risk of pancreatic adenocarcinoma: familial pancreatic cancer, multiple familial melanoma, Peutz-Jeghers syndrome, hereditary chronic...
- Multifocal pancreatic adenocarcinomas identified during preoperative evaluation;
- Performance status and comorbidity profile inappropriate for a major abdominal surgery;
- Contraindication for autologous islet intraportal transplantation
- Current or indicated/scheduled neoadjuvant chemotherapy;
- Extra pancreatic metastasis identified during preoperative evaluation (high-definition cross-sectional imaging with thorax-abdomen-pelvis multi-detection computed tomography or abdominal MRI with T1, T2 and diffusion...
- Need for complex vascular reconstructions (endovascular treatment or release of the arcuate ligament will be not considered as complex vascular reconstructions), major vein reconstructions will exclude the patients...
- evident macroscopically or biologically proved post biliary drainage pancreatitis that jeopardize islet isolation
- Known infection or positive serology performed at screening for human immunodeficiency virus (HIV) infection, Hepatitis B or C virus infection, HTLV infection or syphilis infection.
- Active infection for SARS-CoV-2 virus (positive PCR), which will require rescheduling of the intervention 30 days later.
- Pregnant or breastfeeding woman
- Dihydropyrimidine dehydrogenase total deficiency
- Ethics / regulatory criteria :
- Person unable to understand purposes, benefits and risks of the study and/or unable to provide a written informed consent.
- Person unable to comply with the whole study schedule.
- Person not covered by a health insurance system.
- Person kept in detention and/or receiving psychiatric medical care and/or patients admitted in a social or medical sanatorium.
- Person in an emergency situation.
The study team makes the final eligibility decision.
Where it's taking place
- Lille, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lille, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.