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

Phase 3

Recruiting

Conditions: Ductaal adenocarcinoom van het pancreas
Pancreatic adenocarcinoma
10017990
10017998

Registration Number: NL-OMON46715

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 80

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is microscopically radical resection margins (R0) (these<br /><br>can be in the transection margin of the pancreas but also in the anterior,<br /><br>superior, posterior, inferior margins, i.e. circumferential margins). </p><br>

Secondary Outcome Measures

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