LRAMPS Versus LDP in Selected Early-stage Left-sided Pancreatic Cancer

September 21, 2023 updated by: Xian-Jun Yu, Fudan University

Laparoscopic Radical Antegrade Modular Pancreatosplenectomy Versus Laparoscopic Distal Pancreatosplecnectomy in Selected Left-sided Pancreatic Cancer: a Multicenter Randomized Controlled Clinical Trial

This multicenter randomized controlled clinical trial proposed the criteria for selecting patients with early-stage left-sided pancreatic cancer and aimed to compare the perioperative and oncological outcomes of patients within the criteria who underwent laparoscopic radical antegrade modular pancreatosplenectomy versus laparoscopic distal pancreatosplenectomy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Although prospective comparative studies are lacking, laparoscopic distal pancreatosplenectomy (LDP) was considered to be feasible, safe, and oncologically equivalent for treating pancreatic ductal adenocarcinoma (PDAC). However, the extent of posterior resection and the oncological safety of achieving complete N1 lymph node resection in LDP remain uncertain. Strasberg proposed radical antegrade modular pancreatosplenectomy (RAMPS) for the treatment of resectable left-sided PDAC and confirmed that this technique can achieve negative margins and satisfactory survival. Given the oncological equivalence of laparoscopic radical antegrade modular pancreatosplenectomy (LRAMPS) and its advantages in short-term outcomes, several studies have assessed the feasibility of LRAMPS as the standard treatment for resectable left-sided PDAC. However, previous studies on LRAMPS have mostly included tumors staged T2 and above, and there is currently no research on the routine use of LRAMPS for early-stage tumors. We proposed the criteria for selecting patients with early-stage left-sided PDAC: (1) diameter ≤ 4 cm; (2) located ≥ 1 cm from the celiac trunk; (3) didn't invade the fascial layer behind the pancreas. This multicenter open-label randomized controlled clinical trial aims to compare the perioperative and oncological outcomes of patients within the criteria who underwent LRAMPS versus LDP.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

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

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center
        • Contact:
        • Principal Investigator:
          • Xianjun Yu, MD, PhD
        • Sub-Investigator:
          • Xiaowu Xu, MD

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinically diagnosed as resectable left-sided pancreatic cancer before surgery.
  • Imaging tumor diameter ≤ 4 cm.
  • Located ≥ 1cm from the celiac trunk.
  • Tumor didn't invade the fascial layer behind the pancreas.
  • Be able to comply with research protocol.
  • Voluntary participation and signed informed consent.

Exclusion Criteria:

  • Received neoadjuvant therapy.
  • Presence of liver or other distant metastasis.
  • Multifocal or recurrent disease.
  • History of other malignancies.
  • Simultaneously participating in other clinical trials.

Study Plan

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

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LRAMPS group
Patients who meet the inclusion and exclusion criteria will undergo laparoscopic radical antegrade modular pancreatosplenectomy (LRAMPS) surgery.
Procedure: LRAMPS
For LRAMPS procedure, Gerota's fascia and perirenal fat capsule are removed, and the procedure is divided into anterior LRAMPS and posterior LRAMPS depending on whether the left adrenal gland is resected. The N1 station lymph nodes (i.e., groups 10, 11, and 18) in the body and tail of the pancreas are removed. If the tumor is located near the pancreatic body, the No. 9 lymph node group is additionally removed.
Experimental: LDP group
Patients who meet the inclusion and exclusion criteria will undergo laparoscopic distal pancreatosplecnectomy (LDP) surgery.
Procedure: LDP
For LDP procedure, the dissection plane is located behind the fusion fascia. The N1 station lymph nodes (i.e., groups 10, 11, and 18) in the body and tail of the pancreas are removed. If the tumor is located near the pancreatic body, the No. 9 lymph node group is additionally removed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0 retroperitoneal margin rate
Time Frame: From the date of surgery to 1 month after surgery.
R0 retroperitoneal margin rate diagnosed by postoperative pathological examination.
From the date of surgery to 1 month after surgery.
R0 transection margin rate
Time Frame: From the date of surgery to 1 month after surgery.
R0 transection margin rate diagnosed by postoperative pathological examination.
From the date of surgery to 1 month after surgery.
Lymph node positive rate
Time Frame: From the date of surgery to 1 month after surgery.
Lymph node positive rate diagnosed by postoperative pathological examination.
From the date of surgery to 1 month after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative complication rate
Time Frame: Within 90 days after surgery.
Adverse events that occur during or after the surgery, including the incidence of postoperative complications reported according to the Clavien-Dindo classification, clinical relevant postoperative pancreatic fistula (POPF), postoperative pancreatic hemorrhage (PPH), delayed gastric emptying (DGE), reoperation rate and mortality rate within 90 days after surgery.
Within 90 days after surgery.
Recurrence-free survival (RFS)
Time Frame: Through study completion, an average of 3 year.
The time of surgery to the time of tumor recurrence or death.
Through study completion, an average of 3 year.
Overall survival (OS)
Time Frame: Through study completion, an average of 3 year.
The time from the surgery to death from any cause.
Through study completion, an average of 3 year.
Life quality satisfaction evaluated according to EORTC C30 scale
Time Frame: Through study completion, an average of 3 year.
The patient's health-related quality of life after surgical intervention. It includes physical, emotional, and social aspects of a patient's well-being. This study evaluated quality of life using a telephone survey and the EORTC C30 scales.
Through study completion, an average of 3 year.

Collaborators and Investigators

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

Sponsor

Fudan University

Collaborators

Qilu Hospital of Shandong University
The Third Affiliated Hospital of Soochow University

Investigators

  • Principal Investigator: Xianjun Yu, MD, PhD, Fudan University
  • Study Director: Xiaowu Xu, MD, Fudan University

Publications and helpful links

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

General Publications

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 Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

August 31, 2028

Study Registration Dates

First Submitted

July 2, 2023

First Submitted That Met QC Criteria

July 2, 2023

First Posted (Actual)

July 11, 2023

Study Record Updates

Last Update Posted (Actual)

September 25, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPAC-6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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