C25.0
Conditions
Interventions
Group 1: Triangle procedure:
Partial pancreatoduodenectomy with
- Radical soft tissue dissection along the superior mesenteric artery (level 3 as described by Inoue et al.) for at least 180 degree on
Sponsors
Klinik für Allgemeine, Viszeral- und Transplantationschirurgie, Universitätsklinikum Tübingen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Preoperative inclusion criteria: - Patients with suspected or histologically verified resectable, borderline or locally advanced pancreatic cancer of the pancreatic head (i.e. pancreatic ductal adenocarcinoma, IPMN (Intraductal Papillary Mucinous Neoplasms) carcinoma or periampullary cancer of the pancreatobiliary-type) - Patients scheduled for elective partial pancreatoduodenectomy (irrespective of neoadjuvant therapy) - Assumed resectability in accordance with the surgical protocol for experimental and control intervention as judged by the treating surgeon - Ability of subject to understand character and individual consequences of the clinical trial - Written informed consent - Age =18 years Intraoperative inclusion criteria (prior to randomisation): - No distant metastases - No paraaortic lymph node metastases - Intraoperative confirmation that the patient can be operated according to both surgical methods (experimental or control group)
Exclusion criteria
Exclusion criteria: - Participation in another interventional trial with interference of intervention and outcome of this trial - American Society of Anesthesiologists (ASA) grade > 3 - Distant metastatic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival (DFS) after index operation, defined as the time from randomisation until disease recurrence (local recurrence or metastases) or death from any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rate of a. microscopically complete circumferential resection margin (CRM) clearance (>0.1cm margin clearance, R0(CRM-)) b. microscopic margin clearance =0.1cm (R0(CRM+)) c. microscopic margin involvement (R1) resections according to the 8th edition of the UICC TNM classification 2. Rate of the following PD-associated postoperative complications within 90 days after the index operation: a. Postoperative pancreatic fistula (POPF) as defined by the International Study Group of Pancreatic Surgery (ISGPS) b. Postpancreatectomy haemorrhage (PPH) as defined by the ISGPS c. Delayed gastric emptying as defined by the ISGPS d. Bile leakage as defined by the International Study Group of Liver Surgery (ISGLS) e. Lymphatic fistula as defined by the ISGPS f. Diarrhoea as graded by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 3. All other postoperative complications graded according to the Dindo-Clavien classification within 90 days 4. Overall survival within study period 5. Local recurrence within study period 6. Quality of life according to EORTC QLQ-C30 and PAN26 7. Quality of recovery according to QoR-15 questionnaire 8. Length of primary hospital stay 9. Serious adverse events in both groups | — |
Countries
Germany
Contacts
Public ContactAndré Mihaljevic
Klinik für Allgemeine, Viszeral- und Transplantationschirurgie, Universitätsklinikum Tübingen
Outcome results
None listed