K31.9 T81.9
Conditions
Interventions
Group 1: pylorus preserving group (ppPP)
Group 2: pylorus resecting group (prPD)
Sponsors
LMU Klinikum München Anstalt des öffentlichen Rechts
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients in which a partial pancreatoduodenectomy (PD) needs to be performed Any patient aged 18 years or older scheduled for PD for any indication with written informed consent is eligible
Exclusion criteria
Exclusion criteria: -Patients who participate in another intervention trial interfering with the surgical intervention or the outcome of this Trial -Patients with expected lack of compliance and/or irreconcilable language barriers will be excluded -Classic Whipple operation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy endpoint is the frequency of postoperative DGE (delayed gastric emptying) according to the international ISGPS definition 30 days after index operation, compared between the two intervention groups | — |
Secondary
| Measure | Time frame |
|---|---|
| severe morbidity (Clavien Dindo classification<3b vs =3b), blood loss (ml), 30 day mortality (death from any cause), postoperative hospital stay, insufficiency of the gastro/pylorojejunostomy, operation time, initiation of adjuvant chemotherapy in cancer patients | — |
Countries
Germany
Contacts
Public ContactBernhard Renz
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Klinikum der Universität München Campus Großhadern
Outcome results
None listed