Radical antegrade modular pancreatosplenectomy versus conventional distal pancreatosplenectomy for pancreatic cancer – The multicenter, randomized, controlled RAMPS-Trial

Radical antegrade modular pancreatosplenectomy versus conventional distal pancreatosplenectomy for pancreatic cancer – The multicenter, randomized, controlled RAMPS-Trial - RAMPS-Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00033031

Enrollment

244

Registered

2024-09-20

Start date

2025-02-20

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

C25

Interventions

Group 1: Radical antegrade modular pancreatosplenectomy (RAMPS) Patients with indication for distal pancreatosplenectomy due to malignancy in the pancreatic body or tail randomized to the RAMPS approa

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Planned open or minimally-invasive distal pancreatosplenectomy Resectable cancer of the pancreatic body or tail Age = 18 years American Society of Anesthesiologists (ASA) = III Ability to understand character and individual consequences of the trial Written informed consent

Exclusion criteria

Exclusion criteria: Preoperative exclusion criteria: Distant metastases of pancreatic cancer, Tumors infiltrating surrounding organs or visceral arteries (except of splenic artery), i.e. stage T4 according to the 8th edition of the American Joint Committee on Cancer staging system, Surgery for secondary tumors or metastases involving the pancreas, Participation in another intervention-trial with interference of intervention and/or outcomes of this study Intraoperative exclusion criteria: Intraoperative diagnosis of previously occult metastases that prohibit curative surgical resection Tumor resection technically impossible (local unresectability)

Design outcomes

Primary

Measure	Time frame
The primary endpoint will be the achievement of complete surgical resection with negative margins (R0 resection). Microscopically radical resection margin will be pathologically assessed one-time after the surgery on the specimen according to an international standardized pathologic protocol.	—

Secondary

Measure	Time frame
Oncologic endpoints: lymph node count, overall survival, cancer-specific survival, disease free survival, rates of local and distant recurrence Perioperative endpoints: pancreatic fistula, delayed gastric emptying, post-pancreatectomy hemorrhage, surgical site infection according to CDC criteria, reintervention, duration of surgery, intraoperative blood loss, transfusion, length of ICU stay, length of hospital stay Patient-reported endpoints: Quality of Life (EORTC QLQ-C30 & PAN-26 assessed preoperatively and at 12 and 24 months after surgery) Assessment of safety: Frequency of major complications (Clavien-Dindo = 3)	—

Measure

Time frame

Oncologic endpoints: lymph node count, overall survival, cancer-specific survival, disease free survival, rates of local and distant recurrence Perioperative endpoints: pancreatic fistula, delayed gastric emptying, post-pancreatectomy hemorrhage, surgical site infection according to CDC criteria, reintervention, duration of surgery, intraoperative blood loss, transfusion, length of ICU stay, length of hospital stay Patient-reported endpoints: Quality of Life (EORTC QLQ-C30 & PAN-26 assessed preoperatively and at 12 and 24 months after surgery) Assessment of safety: Frequency of major complications (Clavien-Dindo = 3)

—

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026