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Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for AGC

Primary Purpose

Gastric Cancer, Gastrectomy, Laparoscopic Surgery

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection
Sponsored by
Peking University Cancer Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients age older than 18 years (including 18 years old);
  • The primary lesion is located in the upper or middle third of the stomach, including Siewert II type and Siewert III type adenocarcinoma of the esophagogastric junction;
  • Pathologically confirmed primary gastric adenocarcinoma by endoscopic biopsy (including papillary, tubular, mucinous, signet ring cell and poorly differentiated adenocarcinoma);
  • Preoperative cancer stage cT2-4aN0-3M0 (according to AJCC-7th TNM staging);
  • The Eastern Cooperative Oncology Group performance status of 0 or 1;
  • The American Society of Anesthesiology classes of I, II or III;
  • Signed Informed consent.

Exclusion Criteria:

  • Pregnant or lactating women;
  • Suffering from severe mental disorder;
  • Previous gastrectomy, including endoscopic submucosal dissection and endoscopic mucosal resection;
  • Integrated or enlarged lymph node with maximum diameter larger than 3 cm according to preoperative imaging, including significantly enlarged or bulky No. 10 lymph nodes;
  • Siewert I type adenocarcinoma of the esophagogastric junction;
  • Other malignant diseases (within 5 years);
  • Other illnesses needed operation concurrently;
  • Complications (bleeding, perforation or obstruction) required emergency surgery due to primary gastric malignancy;
  • Pulmonary function tests FEV1 less than 50% of predicted value;
  • Patient suffered from bleeding tendency disease such as hemophilia or took anti-coagulant medication due to deep vein thrombosis.
  • Patients with obvious tumor infiltration in the spleen and splenic vessels which require splenectomy.

Sites / Locations

  • Beijing Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

No. 10 Lymph Node Dissection group

Arm Description

Patients with locally advanced upper or middle third gastric cancer will receive laparoscopic total gastrectomy and D2 lymphadenectomy with spleen-preserving No.10 lymph node dissections

Outcomes

Primary Outcome Measures

the incidence of postoperative complications within 30 days

Secondary Outcome Measures

3-year disease free survival

Full Information

First Posted
October 8, 2018
Last Updated
November 17, 2019
Sponsor
Peking University Cancer Hospital & Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03708783
Brief Title
Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for AGC
Official Title
Study on Short and Long-term Outcome of Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Advanced Middle or Upper Third Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Cancer Hospital & Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to explore the safety and feasibility of laparoscopic spleen-preserving No. 10 lymph node dissection for patients with advanced middle or upper third gastric cancer.
Detailed Description
Radical resection is the primary treatment for patients with advanced middle or upper third gastric cancer. And D2 lymphadenectomy, including No. 10 lymph node dissection, should be performed according to the Japanese treatment guidelines for gastric cancer. Because of the complexity of the anatomy around the spleen, spleen-preserving No. 10 lymph node dissection is difficult. Although Professor Huang from Fujian Medical University Union Hospital has proposed the "Huang's three-step maneuver" to dissect No. 10 lymph node with preserved spleen laparoscopically, such method is far from popularized, especially in North China. In addition, the safety, feasibility and oncological efficacy of this method was not confirmed in such area, either. In this study, a prospective, single center, single-arm, non-inferiority clinical trial will be conducted to evaluate the short and long-term outcome of the laparoscopic spleen-preserving No. 10 lymph node dissection for patients with locally advanced middle or upper third gastric cancer in Beijing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Gastrectomy, Laparoscopic Surgery, Lymphadenectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients with locally advanced upper and middle third gastric cancer will receive laparoscopic total gastrectomy with D2 lymphadenectomy including No. 10 lymph node dissection.
Masking
None (Open Label)
Allocation
N/A
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No. 10 Lymph Node Dissection group
Arm Type
Experimental
Arm Description
Patients with locally advanced upper or middle third gastric cancer will receive laparoscopic total gastrectomy and D2 lymphadenectomy with spleen-preserving No.10 lymph node dissections
Intervention Type
Procedure
Intervention Name(s)
laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection
Intervention Description
For patients with locally advanced upper or middle third gastric cancer, laparoscopic total gastrectomy with D2 lymphadenectomy including spleen-preserving No. 10 lymph node dissection is performed.
Primary Outcome Measure Information:
Title
the incidence of postoperative complications within 30 days
Time Frame
30 days
Secondary Outcome Measure Information:
Title
3-year disease free survival
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients age older than 18 years (including 18 years old); The primary lesion is located in the upper or middle third of the stomach, including Siewert II type and Siewert III type adenocarcinoma of the esophagogastric junction; Pathologically confirmed primary gastric adenocarcinoma by endoscopic biopsy (including papillary, tubular, mucinous, signet ring cell and poorly differentiated adenocarcinoma); Preoperative cancer stage cT2-4aN0-3M0 (according to AJCC-7th TNM staging); The Eastern Cooperative Oncology Group performance status of 0 or 1; The American Society of Anesthesiology classes of I, II or III; Signed Informed consent. Exclusion Criteria: Pregnant or lactating women; Suffering from severe mental disorder; Previous gastrectomy, including endoscopic submucosal dissection and endoscopic mucosal resection; Integrated or enlarged lymph node with maximum diameter larger than 3 cm according to preoperative imaging, including significantly enlarged or bulky No. 10 lymph nodes; Siewert I type adenocarcinoma of the esophagogastric junction; Other malignant diseases (within 5 years); Other illnesses needed operation concurrently; Complications (bleeding, perforation or obstruction) required emergency surgery due to primary gastric malignancy; Pulmonary function tests FEV1 less than 50% of predicted value; Patient suffered from bleeding tendency disease such as hemophilia or took anti-coagulant medication due to deep vein thrombosis. Patients with obvious tumor infiltration in the spleen and splenic vessels which require splenectomy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zaozao Wang
Phone
0086-10-88196851
Email
zaozao83630@sina.com
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangqian Su
Phone
0086-10-88196696
Email
suqiangqian@bjmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for AGC

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