What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are pancreaticoduodenectomy procedure. The registry lists allocation as na. Pancreaticoduodenectomy (PD) is a complex procedure performed in patients with malignant or benign tumors of the pancreatic head and periampullary region, associated with high morbidity and mortality.
They plan to enroll about 100 people at Minya. Taking part typically means a procedure as part of the study plus check-ins.
Official title (unrewritten)
Predictive Risk Factors for Postoperative Pancreatic Fistula After Pancreaticoduodenectomy for Malignancy.
Interventions: pancreaticoduodenectomy procedure
Primary outcome (registry wording): Incidence of clinically relevant post operative pancreatic fistula