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Distal pancreatectomy, minimally invasive or open, for malignancy (DIPLOMA)

Distal pancreatectomy, minimally invasive or open, for malignancy (DIPLOMA) - DIPLOMA-trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46715
Enrollment
80
Registered
2018-01-25
Start date
2018-05-03
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ductaal adenocarcinoom van het pancreas Pancreatic adenocarcinoma

Interventions

Minimally invasive (laparoscopic or robot) distal pancreatectomy

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age equal or above 18 years; Indication for elective distal pancreatectomy for expected PDAC; Upfront (without induction / down-sizing radio- or chemotherapy) resectable PDAC in the pancreatic body or tail; The tumour can be radically resected via both minimally invasive or open surgery according to the local treating team; The patient is fit to undergo distal pancreatectomy, either minimally invasive or open

Exclusion criteria

Exclusion criteria: ASA-score >3 History of chronic pancreatitis Surgery for secondary tumour Distant metastases (M1) Tumour involvement of major vessels Pregnancy Participation in study with interference of study outcomes

Design outcomes

Primary

MeasureTime frame
The primary outcome is microscopically radical resection margins (R0) (these can be in the transection margin of the pancreas but also in the anterior, superior, posterior, inferior margins, i.e. circumferential margins).

Secondary

MeasureTime frame
Secundary endpoints are: - Intraoperative parameters (operative time, blood loss, blood transfusion and conversion) - Postoperative parameters (complications, mortality, re-interventions) - Pathology parameters (tumor size, lymph node retrieval, positive nodes, invasion, grading and staging) - Hospitalization parameters (time to functional recovery, tot hospital sta, readmission, intensive care admission) - Oncology parameters (use of (neo-)adjuvant chemotherapy - Quality of life - Costs

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)