RAMPS VS SRPS for Pancreatic Body and Tail Adenocarcinoma

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Radical Antegrade Modular Pancreatosplenectomy
• Intervention / Treatment: Procedure: Radical antegrade modular pancreatosplenectomy; Procedure: Standard retrograde pancreatosplenectomy

• Study Type: Interventional
• Enrollment (Anticipated): 224
• Phase: Not Applicable

Contacts and Locations

• 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

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
      • Contact: Zhen Huo, PhD; Phone Number: +86-15000082925; Email: generalsurgeon@qq.com
      • Contact: Yuanchi Weng, MD.; Phone Number: +86-13774209138; Email: wyuanchi@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

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 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.	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 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.
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, 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.	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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
estimated blood loss in milliliters	Estimated blood loss will be evaluated based on the vacuum amount, gauze weight and liquid intake	1 day
postoperative pancreatic fistula in percentage	According to the definition of International Study Group on Pancreatic Fistula(ISGPF)	3 months
postpancreatectomy hemorrhage in percentage	Postpancreatectomy hemorrhage is defined by International Study Group on Pancreatic Surgery	3 months
delayed gastric emptying in percentage	Delayed gastric emptying is defined by International Study Group on Pancreatic Surgery	3 months
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
30-day mortality in percentage	Any death within 30 days in postoperative period will be calculated	1 month
90-day mortality in percentage	Any death within 90 days in postoperative period will be calculated	3 months

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 15, 2020
• Primary Completion (Anticipated): February 28, 2022
• Study Completion (Anticipated): February 28, 2027

Study Registration Dates

• First Submitted: January 29, 2020
• First Submitted That Met QC Criteria: February 1, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 1, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Radical antegrade modular pancreatosplenectomy; Standard retrograde pancreatosplenectomy; Pancreatic Body and Tail Adenocarcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: HBP-RCT-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No