Robotic radical antegrade modular pancreatosplenectomy (RAMPS) versus standard retrograde pancreatosplenectomy (SRPS): study protocol for a randomized controlled trial

Abstract

Background: Data from meta-analysis suggest that robotic radical antegrade modular pancreatosplenectomy (RAMPS) is a safe and effective procedure for treating adenocarcinoma in the body or tail of the pancreas, and is oncologically superior to standard retrograde pancreatosplenectomy (SRPS). RAMPS is an operation that actively expands the scope of resection, and achieves a higher R0 resection rate and lymph nodes acquisition through expanded resection. However, previous studies on RAMPS were conducted under open and laparoscopic surgery. Robotic surgery, on the other hand, plays a role in ergonomics and offers several advantages, including less fatigue, tremor filtering, 7°of wrist-like motion, motion scaling, and three-dimensional vision. At present, there is still a worldwide lack of clinical studies to observe the safety and clinical efficacy of robotic RAMPS. Hence, prospective randomized controlled trials (RCTs) comparing robotic RAMPS and SRPS are required. We begin an RCT to compare short-term surgical and oncological outcomes of robotic RAMPS and SRPS in patients undergoing distal pancreatectomy. Methods: This is a randomized, single-center clinical trial. All participants are adult patients with primary pancreatic cancer, who are undergoing RAMPS or SRPS. The primary endpoints are R0 rate (resection margins are classified by a margin to tumor distance ≥ 1 mm). The secondary endpoints are the number of harvested lymph nodes, perioperative complications and perioperative indicators (duration of surgery, blood loss, blood transfusion volume, costs). Discussion: We are undertaking a prospective RCT to evaluate the surgical and oncological outcomes of robotic RAMPS. This procedure may become a standard approach to robotic pancreatosplenectomy.

Critérios De Ressecabilidade Pancreática Para O Tratamento De Câncer: Uma Revisão Integrativa

“…A ressecção do adenocarcinoma de pâncreas, geralmente, não acontece no momento do diagnóstico, pelo avanço da doença primária ou pela presença de metástase (MORALES et al, 2019). No que se refere à sobrevida de pacientes no pós-operatório, além da técnica de ressecção cirúrgica completa, há também a ressecção com margem negativa, as quais são classificadas por uma margem à distância do tumor ≥ 1 mm (R0), uma margem à distância do tumor < 1 mm (R1) ou uma margem macroscopicamente positiva (R2) (ZHANG et al, 2020).…”

“…Outra opção de tratamento seguro para ADP de corpo ou cauda de pâncreas é a pancreatoesplenectomia modular anterógrada radical robótica (RAMPS), método que atinge uma maior ressecção R0 e gânglios linfáticos pela ressecção expandida, sendo oncologicamente superior à pancreatoesplenectomia retrógrada padrão (SRPS). Assim, espera-se no decorrer dos anos que a RAMPS se torne o método cirúrgico padrão para pancreatectomia distal, pois a ressecção radical na margem do retroperitônio permite sobrevida em 5 anos nos pacientes quando comparado à SRPS (ZHANG et al, 2020).…”

Distal pancreatectomy with or without radical approach, vascular resections and splenectomy: Easier does not always mean easy

“…The systematic adoption of the RAMPS procedure has been increasing, particularly in Japan and Korea[ 4 ]. The number of patients eligible for RAMPS is small, and only recently have some prospective randomized trials of RAMPS vs the standard procedure been started[ 4 , 27 , 28 ]. These studies are still enrolling patients, and no definitive results are available yet.…”