NCT06801899Recrutement en cours
ToPanc Trial: Survival After Total Versus Partial Pancreaticoduodenectomy for Adenocarcinoma of the Pancreatic Head, Distal Cholangiocarcinoma, and Ampullary Cancer
Résumé
The goal of this clinical trial is to learn if total removal of the pancreas is a preferable alternative to partial removal in patients with cancer of the pancreatic head who are at high risk of pancreatic leakage. The main question it aims to answer is: Does total pancreas removal improve survival without reducing quality of life compared to partial removal? The only study specific procedures are the collection of 2 blood samples (7.5ml for each time point, preoperatively and during the hospitalisation) and the completion of the questionnaires.
Critères d'inclusion
• Adult patients (age ≥ 18 years) scheduled to undergo PD for highly suspected or histologically proven, resectable pancreatic ductal adenocarcinoma (PDAC), distal cholangiocarcinoma (DCC), and/or ampullary cancer (pancreaticobiliary type) • Suspected pancreas anastomosis at high-risk for development of a postoperative pancreatic fistula (POPF) (grade "D" according to Schuh et al. (29): Estimation by CT scan, MRI, and/or Endoscopic Ultrasound • Written informed consent
Critères d'exclusion
• Duodenal carcinoma, ampullary cancer (intestinal type), neuroendocrine tumors, benign tumors, chronic pancreatitis • Medical conditions that do not allow appreciation of the nature, scope, and possible consequences of the trial as judged by the investigator • Pregnancy. A beta-Human Chorionic Gonadotropin (bHCG) pregnancy test must to be performed for women of child-bearing potential (defined as premenopausal women who have not undergone surgical sterilization) • Inability to follow the study procedures, e.g., due to psychological disorders, dementia, etc.
Contacts
Les coordonnées de l'équipe de l'essai s'affichent sur demande.
Voir la fiche officielle de l'essai- Statut
- Recrutement en cours
- Phase
- Sans phase (N/A)
- Type d'étude
- Interventionnelle
- Pays
- Suisse, Allemagne
- Promoteur
- Insel Gruppe AG, University Hospital Bern(Autre)
- N° de protocole
- 2024-02010
- Pathologies
- Pancreatic Cancer
- Interventions
- Procédure
Traitements évalués
- Total pancreatectomy (TP)
- Partial pancreaticoduodenectomy (PD)
Lieux · 10
- Aarau, SuisseDepartment of General and Visceral Surgery, Kantonsspital AarauRecrute dans ce centre
- Baden, SuisseDepartment of Surgery, Kantonsspital BadenRecrute dans ce centre
- Basel, SuisseDepartment of Visceral Surgery, University Hospital BaselRecrute dans ce centre
- Bern, SuisseInselspital, Bern University HospitalRecrute dans ce centre
- Geneva, SuisseDepartment of Visceral Surgery, University Hospital GenevaRecrute dans ce centre
- Sankt Gallen, SuisseDepartment of General, Visceral, Endocrine and Transplantation Surgery, Kantonsspital St. GallenRecrute dans ce centre
- Zurich, SuisseDepartment of Surgery, Stadtspital Triemli ZürichRecrute dans ce centre
- Zurich, SuisseDepartment of Surgery and Transplantation, University Hospital ZürichRecrute dans ce centre
- Münster, AllemagneDepartment of General, Visceral and Transplantation Surgery, University Hospital MünsterRecrute dans ce centre
- Ulm, AllemagneDepartment of General and Visceral Surgery, University Hospital UlmRecrute dans ce centre
Au total, dans le monde, les 10 centres listés au registre recrutent.
Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 12 août 2026).
Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.
Voir aussi
Autres versions
Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.