Distal Pancreatectomy – A randomised controlled trial to compare minimal-invasive distal pancreatectomy to open resection (DISPACT-2 Trial)

Distal Pancreatectomy – A randomised controlled trial to compare minimal-invasive distal pancreatectomy to open resection (DISPACT-2 Trial) - DISPACT 2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00014011

Enrollment

294

Registered

2018-03-20

Start date

2020-08-13

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

C25.1 C25.2 C25.3 C25.4 C25.7 K86.0 K86.1 D13.6

Interventions

Group 1: Minimal-invasive distal pancreatectomy (MIDP) Group 2: Open distal pancreatectomy (ODP)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Planned distal pancreatectomy with or without splenectomy for any indication - Age = 18 years - Ability of subject to understand character and individual consequences of the clinical trial - Written informed consent

Exclusion criteria

Exclusion criteria: - Patients scheduled for a pancreatic resection other than distal pancreatectomy - Distant organ metastases or tumour infiltration of the superior mesenteric vein, superior mesenteric artery or hepatic artery - Infiltration of adjacent organs - CA 19-9 >1000 IU/ml - ASA >3 - Prior major open abdominal surgery - Participation in another intervention-trial with interference of intervention and outcome of this study - Lack of compliance and lack of written informed consent

Design outcomes

Primary

Measure	Time frame
Postoperative mortality and morbidity assessed as comprehensive complication index (CCI) 3 months after intervention.	—

Secondary

Measure	Time frame
- Operation time - Intraoperative blood loss - Conversion rate (minimal-invasive group) - Days on ICU - Pain (NRS) - Mobility - Length of hospital stay - Time to functional recovery - Pancreas-associated morbidity (pancreatic fistula, delayed gastric emptying, postoperative hemorrhage) - Surgical site infection - Re-intervention rate - Time to return to work - Quality of Life (EORTC QLQ-C30 and PAN 28 (CP)) - Incisional hernia rate - Survival rate after 12 and 24 months - R0 / R1 resection rates - Lymph node count in oncological group - DRG case cost	—

Measure

Time frame

- Operation time - Intraoperative blood loss - Conversion rate (minimal-invasive group) - Days on ICU - Pain (NRS) - Mobility - Length of hospital stay - Time to functional recovery - Pancreas-associated morbidity (pancreatic fistula, delayed gastric emptying, postoperative hemorrhage) - Surgical site infection - Re-intervention rate - Time to return to work - Quality of Life (EORTC QLQ-C30 and PAN 28 (CP)) - Incisional hernia rate - Survival rate after 12 and 24 months - R0 / R1 resection rates - Lymph node count in oncological group - DRG case cost

—

Countries

Germany, Slovenia, United Kingdom

Contacts

Public ContactRosa Klotz

Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Heidelberg

rosa.klotz@med.uni-heidelberg.de06221-5634726

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026