Radical antegrade modular pancreatosplenectomy versus conventional left pancreatectomy for pancreatic cancer: study protocol for the multicentre randomized clinical RAMPS trial.

BACKGROUND

Complete surgical resection (R0 resection) is crucial for overall and disease-free survival in patients with pancreatic cancer undergoing curative surgery. The radical antegrade modular pancreatosplenectomy (RAMPS) procedure was developed to increase achievement of R0 resection margins for tumour resections of the pancreatic body and tail. By extending the posterior dissection plane, a more radical surgical resection can be achieved, as this is the most frequent site of positive margins in conventional left pancreatectomy. RAMPS includes a standardized lymph node dissection and early control of the splenic vessels. Feasibility and safety have already been demonstrated and retrospective studies have shown promising results regarding higher proportions of R0 resection and lymph node counts. To date, high-quality evidence from randomized clinical trials investigating the oncological benefit of RAMPS (that is, resection margin status, disease-free and overall survival) for this patient cohort is lacking.

METHODS

The RAMPS trial is a multicentre, randomized clinical, patient and assessor-blinded, confirmatory, superiority trial. In all, 122 patients with an indication for left pancreatectomy due to malignancy of the pancreatic body or tail will be required in each study arm to achieve 80% power at a significance level of 0.025; patients will be randomized to either the RAMPS approach or conventional left pancreatectomy in a 1 : 1 ratio. Patients will be recruited over a 30-month enrolment period. The primary outcome will be the achievement of R0 resections. Secondary outcomes include survival and surgical, functional, and patient-reported outcomes with a 3-year follow-up.

CONCLUSION

The primary objective of the RAMPS trial is to demonstrate the superiority of the RAMPS approach over standard left pancreatectomy in improving the achievement of R0 resection and, consequently, long-term oncological patient outcomes. RAMPS could be established as the new surgical standard for tumour resection in patients with pancreatic cancer in the body or tail of the pancreas. Registration number: DRKS00033031 (https://www.bfarm.de/EN/BfArM/Tasks/German-Clinical-Trials-Register/_node.html).