Clinical trial NCT04253847: RAMPS VS SRPS for Pancreatic Body and Tail Adenocarcinoma
Official title: Radical Antegrade Modular Pancreatosplenectomy Versus Standard Retrograde Pancreatosplenectomy on the Survival and Prognosis for Resectable Body and Tail Pancreatic Ductal Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Radical Antegrade Modular Pancreatosplenectomy
Keywords: Radical antegrade modular pancreatosplenectomy
Standard retrograde pancreatosplenectomy
Pancreatic Body and Tail Adenocarcinoma
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Overall survival
timeFrame: 21 months
Secondary outcomes:
measure: Disease free survival
timeFrame: 11 months
measure: R0 resection rate
timeFrame: 1 month
measure: retrieved lymph nodes
timeFrame: 1 month
Other outcomes:
measure: operation time in minutes
timeFrame: 1 day
measure: estimated blood loss in milliliters
timeFrame: 1 day
measure: postoperative pancreatic fistula in percentage
timeFrame: 3 months
measure: postpancreatectomy hemorrhage in percentage
timeFrame: 3 months
measure: delayed gastric emptying in percentage
timeFrame: 3 months
measure: Surgical site infection in percentage
timeFrame: 3 months
measure: 30-day mortality in percentage
timeFrame: 1 month
measure: 90-day mortality in percentage
timeFrame: 3 months
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
References: