Back to resultsRAMPS VS SRPS for Pancreatic Body and Tail Adenocarcinoma
Primary Purpose
Radical Antegrade Modular Pancreatosplenectomy
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Radical antegrade modular pancreatosplenectomy
Standard retrograde pancreatosplenectomy
Sponsored by
About this trial
This is an interventional treatment trial for Radical Antegrade Modular Pancreatosplenectomy focused on measuring Radical antegrade modular pancreatosplenectomy, Standard retrograde pancreatosplenectomy, Pancreatic Body and Tail Adenocarcinoma
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.
Sites / Locations
- Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
RAMPS group
SRPS group
Arm Description
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 and left of superior mesenteric artery, as well as the peripheral nerve of celiac trunk. Thirdly, the transection platform is in the pancreatic neck, which is mandatory. At last, left prerenal fascia will be resected. When the tumor abuts or infiltrates the left adrenal gland, left adrenalectomy will be performed, which is also called "posterior approach RAMPS". While in normal cases, left adrenal gland will be preserved.
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, 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, but transection at pancreatic neck is not mandatory. At last, the surgical plane is anterior to the left renal fascia, prerenal fascia will be preserved.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04253847
Brief Title
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
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 15, 2020 (Anticipated)
Primary Completion Date
February 28, 2022 (Anticipated)
Study Completion Date
February 28, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radical Antegrade Modular Pancreatosplenectomy
Keywords
Radical antegrade modular pancreatosplenectomy, Standard retrograde pancreatosplenectomy, Pancreatic Body and Tail Adenocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
The participant will not know which group they are assigned to, but the surgeons know which group they were randomly assigned to.
Allocation
Randomized
Enrollment
224 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RAMPS group
Arm Type
Experimental
Arm Description
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 and left of superior mesenteric artery, as well as the peripheral nerve of celiac trunk. Thirdly, the transection platform is in the pancreatic neck, which is mandatory. At last, left prerenal fascia will be resected. When the tumor abuts or infiltrates the left adrenal gland, left adrenalectomy will be performed, which is also called "posterior approach RAMPS". While in normal cases, left adrenal gland will be preserved.
Arm Title
SRPS group
Arm Type
Active Comparator
Arm Description
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, 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, but transection at pancreatic neck is not mandatory. At last, the surgical plane is anterior to the left renal fascia, prerenal fascia will be preserved.
Intervention Type
Procedure
Intervention Name(s)
Radical antegrade modular pancreatosplenectomy
Intervention Description
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 and left of superior mesenteric artery, as well as the peripheral nerve of celiac trunk. Thirdly, the transection platform is in the pancreatic neck, which is mandatory. At last, left prerenal fascia will be resected. When the tumor abuts or infiltrates the left adrenal gland, left adrenalectomy will be performed, which is also called "posterior approach RAMPS". While in normal cases, left adrenal gland will be preserved.
Intervention Type
Procedure
Intervention Name(s)
Standard retrograde pancreatosplenectomy
Intervention Description
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, but transection at pancreatic neck is not mandatory. At last, the surgical plane is anterior to the left renal fascia, prerenal fascia will be preserved.
Primary Outcome Measure Information:
Title
Overall survival
Description
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.
Time Frame
21 months
Secondary Outcome Measure Information:
Title
Disease free survival
Description
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.
Time Frame
11 months
Title
R0 resection rate
Description
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.
Time Frame
1 month
Title
retrieved lymph nodes
Description
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.
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
operation time in minutes
Description
Operation time means "skin to skin"time (from the surgeon start to incise the skin to the last suture of the skin)
Time Frame
1 day
Title
estimated blood loss in milliliters
Description
Estimated blood loss will be evaluated based on the vacuum amount, gauze weight and liquid intake
Time Frame
1 day
Title
postoperative pancreatic fistula in percentage
Description
According to the definition of International Study Group on Pancreatic Fistula(ISGPF)
Time Frame
3 months
Title
postpancreatectomy hemorrhage in percentage
Description
Postpancreatectomy hemorrhage is defined by International Study Group on Pancreatic Surgery
Time Frame
3 months
Title
delayed gastric emptying in percentage
Description
Delayed gastric emptying is defined by International Study Group on Pancreatic Surgery
Time Frame
3 months
Title
Surgical site infection in percentage
Description
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
Time Frame
3 months
Title
30-day mortality in percentage
Description
Any death within 30 days in postoperative period will be calculated
Time Frame
1 month
Title
90-day mortality in percentage
Description
Any death within 90 days in postoperative period will be calculated
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuanchi Weng, MD
Phone
+86-13774209138
Email
wyuanchi@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhen Huo, PhD
Phone
+86-15000082925
Email
generalsurgeon@qq.com
Facility Information:
Facility Name
Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuanchi Weng, MD.
Phone
+86-13774209138
Email
wyuanchi@126.com
First Name & Middle Initial & Last Name & Degree
Zhen Huo, PhD
Phone
+86-15000082925
Email
generalsurgeon@qq.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
RAMPS VS SRPS for Pancreatic Body and Tail Adenocarcinoma
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