Radical Antegrade Modular Pancreatosplenectomy Clinical Trial
Official title:
Radical Antegrade Modular Pancreatosplenectomy Versus Standard Retrograde Pancreatosplenectomy on the Survival and Prognosis for Resectable Body and Tail Pancreatic Ductal Adenocarcinoma
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.
| Status | Not yet recruiting |
| Enrollment | 224 |
| Est. completion date | February 28, 2027 |
| Est. primary completion date | February 28, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Ruijin Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | operation time in minutes | Operation time means "skin to skin"time (from the surgeon start to incise the skin to the last suture of the skin) | 1 day | |
| Other | estimated blood loss in milliliters | Estimated blood loss will be evaluated based on the vacuum amount, gauze weight and liquid intake | 1 day | |
| Other | postoperative pancreatic fistula in percentage | According to the definition of International Study Group on Pancreatic Fistula(ISGPF) | 3 months | |
| Other | postpancreatectomy hemorrhage in percentage | Postpancreatectomy hemorrhage is defined by International Study Group on Pancreatic Surgery | 3 months | |
| Other | delayed gastric emptying in percentage | Delayed gastric emptying is defined by International Study Group on Pancreatic Surgery | 3 months | |
| Other | Surgical site infection in percentage | Surgical site infections are defined by the Center for Disease Control and Prevention (CDC) definition, and diagnosed by positive pathogen culture in 2 weeks from surgery | 3 months | |
| Other | 30-day mortality in percentage | Any death within 30 days in postoperative period will be calculated | 1 month | |
| Other | 90-day mortality in percentage | Any death within 90 days in postoperative period will be calculated | 3 months | |
| Primary | Overall survival | Overall survival was defined as the time from surgery to either death or last follow-up. Patients will be observed or contacted every 2 months in the first 2 years after surgery and then every 3 months thereafter. Overall survival measurement will be based on patient's survival status and what is the date of death if the patient is not alive. | 21 months | |
| Secondary | Disease free survival | DFS was calculated from the date of surgery to the date of recurrence or last follow-up if recurrence did not occur. Recurrence was diagnosed by imaging examination like CT, MRI, PET-CT and PET-MRI. | 11 months | |
| Secondary | R0 resection rate | R0 resection was defined as absence of malignant cells within 1 mm from the resection margin using the Royal College of Pathologists definition. The assessment of the margin status will be done by pathologists. | 1 month | |
| Secondary | retrieved lymph nodes | The dissected lymph nodes will be sent to pathology department and the pathologists will separate the lymph nodes and give reports about how many lymph nodes are found and if the lymph nodes are positive or negative. | 1 month |