RAMPS VS SRPS for Pancreatic Body and Tail Adenocarcinoma

Официальное название

Radical Antegrade Modular Pancreatosplenectomy Versus Standard Retrograde Pancreatosplenectomy on the Survival and Prognosis for Resectable Body and Tail Pancreatic Ductal Adenocarcinoma

Обзор

Two arms RCT is design, patients with pancreatic body or tail adenocarcinoma will be randomly assigned to the Radical Antegrade Modular Pancreaticosplenectomy (RAMPS) group or Standard Retrograde Pancreatosplenectomy (SRPS) group. The primary objective is to evaluate the effect of RAMPS on the overall survival of patients with resectable body and tail pancreatic ductal adenocarcinoma. And the secondary objective is to evaluate the disease-free survival, R0 resection rate, number of retrieved lymph nodes and perioperative outcomes like postoperative complication rate, severe complications, mortality and functional recovery time between the experimental group and control group.

Вмешательства

• Процедура Radical antegrade modular pancreatosplenectomy
  Radical antegrade modular pancreatosplenectomy (RAMPS) includes the following aspects. Firstly, the surgical approach is "antegrade", which means from the right to the left, the pancreatic neck will be transected at first and the spleen will be seperated at last. Secondly, lymph nodes dissection includes not only the regional lymph nodes(No.10,11,18 lymph nodes), but also N1 station lymph nodes (N1: 6, 8a, 8p, 12a2/b2/p2, 13a/b, 14b/c/d, 14v, 17a/b), No.7, 9 lymph nodes, the lymph nodes anterior
• Процедура Standard retrograde pancreatosplenectomy
  Standard retrograde pancreatosplenectomy(SRPS) includes several aspects. Firstly, the surgical approach is "retrograde", which means from the left to the right, spleen will be seperated at first and the pancreas will be transected later on. Secondly, only the regional lymph nodes will be dissected, which include No.10, No.11, No.18 lymph nodes, and No.9 lymph nodes should be dissected only when the lesion is in pancreatic neck. Thirdly, the transection platform is in the left side of the lesion,

Первичные конечные точки

• Overall survival [Срок оценки: 21 months]

Вторичные конечные точки (3)

• Disease free survival [Срок оценки: 11 months]
• R0 resection rate [Срок оценки: 1 month]
• retrieved lymph nodes [Срок оценки: 1 month]

Критерии участия

Критерии включения

• Age 18-80 years old;
• Resectable pancreatic body and tail ductal adenocarcinoma with both preoperative and intraoperative evaluation(refer to NCCN guideline 2018 of Pancreatic Cancer);
• ECOG Performance Status 0-1;
• Adenocarcinoma of pancreatic body and tail duct, without distant metastasis and ascites;
• The estimated survival time is ≥ 3 months;
• Follow-up in time and obey the research requirements;
• Be voluntary to this clinical trial and can sign the informed consent;
• Normal hematological index (Leukocyte, platelet, liver function, renal function, DIC, electrolyte index, Hb >10g/dL).

Критерии исключения

• The patients with distant metastasis according to preoperative tumor staging;
• Patients with recurrent pancreatic ductal adenocarcinoma;
• The artery or vein is involved and could not be resected or reconstructed(according to preoperative evaluation or intraoperative evaluation after exploration);
• Patients with cardiopulmonary disfunction and cannot tolerate operation;
• The patients accepted neoadjuvant chemotherapy and radiotherapy before operation;
• Patients with other malignancies or hematopathy
• Before the operation, the total bilirubin was more than 250 μmol/L without preoperative biliary drainage or after biliary drainage, the total bilirubin was still more than 250 μmol/L;
• Pregnancy diagnosed, planned pregnancy and lactating female patients
• Refusal to sign consent.
• Intraoperative exclusion include:Tumor metastasis; not pancreatic primary disease; unresectable pancreatic body/tail adenocarcinoma
• Postoperative exclusion include: not pancreatic ductal adenocarcinoma according to pathological examination.
• Withdrawal of informed consent;
• Willingness to withdraw from the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT04253847 · HBP-RCT-005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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