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Clinical Trials in France / NCT02872571
Active, not recruiting Phase 1/2

Evaluation of the Efficacy of Intramuscular Islet Autograft After Extensive Pancreatectomy

NCT02872571 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Lille
Phase
Phase 1/2
Started
2013-03
Last updated
2026-04-22

Condition(s) studied

Disorder of Endocrine Pancreas

Investigational drug(s) / intervention(s)

Intramuscular Islet Autograft

Intramuscular Islet Autograft: Intramuscular Islet Autograft After Extensive Pancreatectomy

Study summary

The liver may not be an optimal site for islet transplantation due to obstacles by an instant blood-mediated inflammatory response, and low revascularization of transplanted islets. Therefore, intramuscular islet transplantation offers an attractive alternative, based on its simplicity, enabling easier access for noninvasive graft imaging and cell explantation.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: age over 18 years indication for pancreatectomy for benign pancreatic disease not genetically determined (chronic pancreatitis, ductal lesions, neuroendocrine or cystic tumors) or pancreatic trauma Exclusion Criteria: Patients with suspected lesion genetically determined or malignant on the basis of preoperative and / or during surgical exploration and / or during pathological examination Refusal to sign the consent form Patient not affiliated with a social security scheme Pregnant or lactating women Persons deprived of liberty, person under guardianship

Primary outcome measure(s)

  • the percentage of patients with a functioning graft in the arm 3 months after autograft. — 3 months
    Graft function will be estimated by the difference in insulin response between the two arms after the test stimulus by arginine (Acute Insulin Response or AIRarg) .The graft will be considered functional (success) when the insulin response in the grafted arm will be at least 30% higher compared to the other arm, 3 months after transplantation.

Trial sites (4)

FacilityCityRegionStatus
Chu Amiens Picardie Amiens France
CHRU, Hôpital Claude Huriez Lille France
Institut Paoli Calmettes Marseille France
CHU Rouen Rouen France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02872571 on ClinicalTrials.gov ↗ ← All trials in France