Pancreatic head resection or total pancreatectomy with islet autotransplantation (IATx) in patients with periampullary cancer and high risk profile for the development of postoperative pancreatic fistula (POPF) - XandTX Trial

Conditions

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

Brief summary

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

Detailed description

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

Sebastian Hempel, Fiona R. Kolbinger, Florian Oehme, Olga Radulova‐Mauersberger, Janine Schmid et al. (13 authors)

PLoS ONE2025-07-28

10.1371/journal.pone.0327949

Detailed visit plan.

Sebastian Hempel (11745395), Fiona R. Kolbinger (4688002), Florian Oehme (6893285), Olga Radulova-Mauersberger (17105391), Janine Schmid (21800012) et al. (13 authors)

OPAL (Open@LaTrobe) (La Trobe University)2025-07-28

10.1371/journal.pone.0327949.s001

SPIRIT checklist.

Sebastian Hempel (11745395), Fiona R. Kolbinger (4688002), Florian Oehme (6893285), Olga Radulova-Mauersberger (17105391), Janine Schmid (21800012) et al. (13 authors)

OPAL (Open@LaTrobe) (La Trobe University)2025-07-28

10.1371/journal.pone.0327949.s002

Interventions

DRUGAutologous pancreatic islets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Duration between surgery and the date of the decision "fit for adjuvant treatment" (postoperative day X)	—

Secondary

Measure	Time frame
Duration between surgery and the actual start of adjuvant therapy, Perioperative morbidity and mortality, Number and type of adverse events and serious adverse events, Quality of life (post-surgery, EORTC QLQ-C30/Pan26), Metabolic outcome, Oncological long term course (60 months)	—

Countries

Germany

Outcome results

None listed