Extensive Intraoperative Peritoneal Lavage After Curative Gastrectomy for Locally Advanced Gastric Cancer (SEIPLUS) (SEIPLUS)

February 20, 2019 updated by: Dazhi Xu, Sun Yat-sen University

A Prospective, Multicentral, Open-label, Randomized, Controlled Clinical Trial to Investigation the Value of Extensive Intraoperative Peritoneal Lavage After Curative Gastrectomy for Locally Advanced Gastric Cancer

The investigators study aims to explore the potential function of extensive intraoperative peritoneal lavage in improving the overall survival and progression-free survival for locally advanced gastric cancer after curative resection.

Hypothesis: Overall survival and progression-free survival of locally advanced gastric cancer are improved by extensive intraoperative peritoneal lavage.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Gastric cancer has been one of the most frequently common cancers and remains the third leading cause of death among malignant tumors all over the world. Surgery has always been considered as the most effective treatment. While significant surgical technique and perioperative management have dramatically improved the survival of patients with advanced gastric cancer, patients with T4 stage or serosal-positive gastric cancer often suffer from recurrence as peritoneal dissemination, and the prognosis of those patients is extremely poor. Despite curatively resected, Peritoneal metastasis is completed by the implantation of peritoneal free cancer cells exfoliated from serosa-invasive tumors. Therefore, things need to be done to eliminate the free exfoliated cancer cells on the peritoneal lining in order to reduce the risk of peritoneal recurrence.

A multi-institutional prospective, randomized trial has been launched by Kuramoto recently. The trail was intended to demonstrate the superiority in overall survival of addition of Extensive Intraoperative peritoneal Lavage (EIPL) to standard treatment in patients with≥T3 carcinoma of stomach. Based on the'limiting dilution theory', after total or distal gastrectomy with D2 lymphadenectomy, the peritoneal cavity is extensively rinsed 10 times with 1 L physiological saline at a time, followed by complete aspiration of the fluid. In total, 10 L saline is to be used. In this study, the EIPL-IPC group had a significantly lower incidence of peritoneal recurrence. Furthermore, the 5-year overall survival rate of the patients in the EIPL-IPC group (43.8%) was significantly better than that of the intraperitoneal chemotherapy (IPC) group (4.6%) and the surgery-alone group (0%). All in all, EIPL is easy to carry out, safe and inexpensive. Therefore, gastrectomy with EIPL will be a new standard treatment of gastric cancer.

To ensure the quality of the study, two interim analyses will be planned at the half and the completion of the study respectively. The Data and Safety Monitoring Committee will independently review the interim analysis and stop the study ahead of schedule if necessary. Furthermore, to improve the study progress and quality, the in-house interim monitoring will be performed.

Study Type

Interventional

Enrollment (Actual)

508

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 Locations

  • China
      • Tianjin, China
        • Tianjin Medical University Cancer Institute and Hospital
    • Anhui
      • Anqing, Anhui, China
        • Anqing Municipal Hospital
      • Hefei, Anhui, China
        • Anhui Provincial Hospital
      • Hefei, Anhui, China
        • The First Affiliated Hospital of Anhui Medical University
      • Wuhu, Anhui, China
        • First Affiliated Hospital of Wannan Medical College
    • Guangdong
      • Guangzhou, Guangdong, China
        • Cancer center of Sun Yat-sen University
      • Guangzhou, Guangdong, China
        • Guangdong Provincial Hospital of Traditional Chinese Medicine
      • Guangzhou, Guangdong, China
        • The First Affiliated Hospital of Guangdong Pharmaceutical University
      • Guangzhou, Guangdong, China
        • Yuebei People's Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Jiangsu Cancer Institute & Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Jiangxi Provincial Cancer Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Second Affiliated Hospital, School of Medicine, Zhejiang University
      • Lishui, Zhejiang, China
        • Lishui Hospital of Zhejiang University

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Lower age limit of research subjects 18 years old and upper age limit of 80 years old.
  2. ECOG score standard (ECOG）performance status of 0 or 1 and expected to survive more than 6 months.
  3. Without any other malignancies.
  4. Written informed consent from the patient.
  5. Histologically proven primary gastric adenocarcinoma.
  6. Patients planned for open gastrectomy.
  7. Patients who have T3 (subserosal) or T4 (serosal) disease based on Ultrasound gastroscopy and intra-operative inspection with any N staging and M0 gastric cancer.
  8. No preoperative neoadjuvant chemotherapy.
  9. Length of esophageal invasion≤3cm and no need of thoracotomy for resection.

  10. Intraoperative inclusion criteria:

    1. Clinically T3, T4a or T4b.
    2. Clinically H0 and M0. No peritoneal dissemination or Distant metastases.
    3. Possible for R0 surgery.

Exclusion Criteria:

  1. Female in pregnancy or lactation.
  2. Supraclavicular lymph nodes metastases，pelvis or ovarian implantation，peritoneal dissemination，liver，lung and bone metastases.
  3. Massive ascites or cachexia.
  4. Patients participating in any other clinical trails currently，or participated in other trails within 1 months.
  5. Without a history of stomach or esophageal cancers, including stromal tumor，sarcoma，lymphoma and carcinoid.
  6. Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.
  7. Patients with poor compliance or considered to be poor compliance.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Extensive Intraoperative Peritoneal Lavage
Gastrectomy with D2 lymphadenectomy is performed. The peritoneal cavity of subject will be washed with 10 liters of warmed normal saline (1 liter per cycle for 10 cycles), followed by complete aspiration of the fluid . The abdomen will be closed as per standard.
Other: Extensive Intraoperative Peritoneal Lavage
Extensive Intraoperative Peritoneal Lavage
Other Names:
  • EIPL
No Intervention: Standard Treatment
Gastrectomy with D2 lymphadenectomy is performed. The peritoneal lavage will be done < 3 cycles with 3 liters or less of warmed normal saline. The abdomen will be closed as per standard.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 3-year
The survival rate between the surgery to the 3rd year due to all-cause death or last follow-up.
3-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: 3-year
The progression-free or all-cause death rate between the surgery and the 3rd year.
3-year
Peritoneal recurrence
Time Frame: 3-year
The Peritoneal recurrence rate between the surgery and the 3rd year
3-year
Postoperative complications
Time Frame: an average of 10 days
complications such bleeding, infection, obstruction and leakage
an average of 10 days
Post-operative quality of life
Time Frame: an average of 10 days
The postoperative quality of life will be assessed by factors such as Swallowing，Pain and discomfort，Dietary restrictions, Upper gastrointestinal symptoms, mental status and others.
an average of 10 days

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Collaborators

The First Affiliated Hospital of Anhui Medical University
Guangdong Provincial Hospital of Traditional Chinese Medicine
Second Affiliated Hospital, School of Medicine, Zhejiang University
Tianjin Medical University Cancer Institute and Hospital
Jiangxi Provincial Cancer Hospital
Jiangsu Cancer Institute & Hospital
Anhui Provincial Hospital
Anqing Municipal Hospital
Yuebei People's Hospital
The First Affiliated Hospital of Guangdong Pharmaceutical University
First Affiliated Hospital of Wannan Medical College
Lishui hospital of Zhejiang 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

Helpful Links

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

March 1, 2016

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

March 28, 2016

First Submitted That Met QC Criteria

April 16, 2016

First Posted (Estimate)

April 20, 2016

Study Record Updates

Last Update Posted (Actual)

February 21, 2019

Last Update Submitted That Met QC Criteria

February 20, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEIPLUS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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