RAMPS VS SRPS For Pancreatic Body And Tail Adenocarcinoma

Study Overview

RAMPS VS SRPS for Pancreatic Body and Tail 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.

N/A

Radical Antegrade Modular Pancreatosplenectomy

PROCEDURE: Radical antegrade modular pancreatosplenectomy
PROCEDURE: Standard retrograde pancreatosplenectomy

HBP-RCT-005

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-01-29	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-02-01
First Submitted that Met QC Criteria 2020-02-01	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-02-05
First Posted (ACTUAL) 2020-02-05	Results First Posted N/A	Last Verified 2020-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Single

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: RAMPS group 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	PROCEDURE: 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
ACTIVE_COMPARATOR: SRPS group Standard retrograde pancreatosplenectomy(SRPS) includes several key points. 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, o	PROCEDURE: 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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: RAMPS group

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

PROCEDURE: 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

ACTIVE_COMPARATOR: SRPS group

Standard retrograde pancreatosplenectomy(SRPS) includes several key points. 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, o

PROCEDURE: 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

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
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
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
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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Yuanchi Weng, MD

Phone Number: +86-13774209138

Email: wyuanchi@126.com

Study Contact Backup

Name: Zhen Huo, PhD

Phone Number: +86-15000082925

Email: generalsurgeon@qq.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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).

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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