Conventional partial pancreatoduodenectomy versus an uncinate first, extended partial pancreatoduodenectomy approach for the resection of pancreatic head ductal adenocarcinoma (PancER)

Not Applicable

Recruiting

Conditions: C25.0
C25.3
C25.8
Head of pancreas
Pancreatic duct
Overlapping lesion of pancreas

Registration Number: DRKS00013552

Lead Sponsor: niversitätsklinikum Heidelberg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 180

Inclusion Criteria

Patients scheduled for elective partial pancreatoduodenectomy for suspected pancreatic ductal adenocarcinoma of the pancreatic head
- Ability of subject to understand character and individual consequences of the clinical trial
- Written informed consent
- Age =18 years

Exclusion Criteria

- Status post neoadjuvant therapy for the suspected pancreatic ductal adenocarcinoma
- Participation in another interventional trial with interference of intervention and outcome of this Trial
- American Society of Anesthesiologists (ASA) grade > 3
- Pregnant or lactating women

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of curative resections defined as microscopically complete (>0.1cm margin clearance; R0) and microscopic margin clearance <0.1cm (R0(CRM+)) resections according to a standardized protocol for pathologic evaluation

Secondary Outcome Measures

Name	Time	Method
1. Rate of superficial and deep surgical site infections according to CDC criteria within 30 days after the index operation in both groups <br>2. Rate of the following postoperative complications: <br>- Postoperative pancreatic fistula (POPF) as defined by the ISGPS <br>- Postpancreatectomy hemorrhage as defined by the ISGPS <br>- Delayed gastric emptying as defined by the ISGPS <br>- Lymphatic fistula as defined by the ISGPS<br>- Diarrhea as defined and graded by the CTCAE version 4.03 <br>- Other postoperative complications graded according to the Clavien-Dindo classification <br>3. Overall survival within 2 years<br>4. Local recurrence within 2 years<br>5. Quality of life according to EORTC QLQ-C30 and PAN26<br>6. Length of primary hospital stay in days <br>7. Serious adverse events in both groups <br>