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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00013552

Enrollment

180

Registered

2018-01-02

Start date

2018-04-10

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

C25.0 C25.3 C25.8

Interventions

Group 1: Extended partial pancreatoduodenectomy with „Uncinate first“ method Group 2: Conventional partial pancreatoduodenectomy

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactAndré Mihaljevic

Klinik für Allgemein-, Viszeral- und TransplantationschirurgieUniversitätsklinikum Heidelberg

andre.mihaljevic@med.uni-heidelberg.de06221-5636986

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 11, 2026