Association of pancreatic PArenchymal RISk factors with postoperative pancreatic fistula after partial pancreaticoduodenectomy - PARIS study

Association of pancreatic PArenchymal RISk factors with postoperative pancreatic fistula after partial pancreaticoduodenectomy - PARIS study - PARIS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00017184

Enrollment

200

Registered

2019-07-05

Start date

2020-01-21

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

Scheduled elective partial pancreaticoduodenectomy

Interventions

Group 1: PARIS is a single arm observational study enrolling patients who are scheduled a partial or total pancreatic resection. The aim of the study is to investigate whether pancreatic parenchymal c

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Scheduled for elective partial pancreaticoduodenectomy 2. Ability of subject to understand character and individual consequences of the clinical trial 3. Age = 18 years 4. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Participation in an interventional trial with interference of outcome of this study 2. Patients with a legal guardian

Design outcomes

Primary

Measure	Time frame
Association between parenchymal characteristics of the pancreas and postoperative pancreatic fistula (POPF) according to the ISGPS definition	—

Secondary

Measure	Time frame
1. Delayed gastric emptying as defined by the ISGPS within 30 days after the index operation. 2. Postpancreatectomy haemorrhage as defined by the ISGPS within 30 days after the index operation. 3. Chlye leak as defined by the ISGPS within 30 days after the index operation. 4. Bile leak as defined by the ISGLS 5. Postoperative morbidity and mortality according to Dindo-Clavien within 30 days after the index operation. 6. Length of hospital stay in days after index operation	—

Measure

Time frame

1. Delayed gastric emptying as defined by the ISGPS within 30 days after the index operation. 2. Postpancreatectomy haemorrhage as defined by the ISGPS within 30 days after the index operation. 3. Chlye leak as defined by the ISGPS within 30 days after the index operation. 4. Bile leak as defined by the ISGLS 5. Postoperative morbidity and mortality according to Dindo-Clavien within 30 days after the index operation. 6. Length of hospital stay in days after index operation

—

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 12, 2026