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

Study on Short and Long-term Outcome of Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Advanced Middle or Upper Third Gastric Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Laparoscopic Surgery; Gastric Cancer; Gastrectomy; Lymphadenectomy
• Intervention / Treatment: Procedure: laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zaozao Wang; Phone Number: 0086-10-88196851; Email: zaozao83630@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Beijing Cancer Hospital
      • Contact: Xiangqian Su; Phone Number: 0086-10-88196696; Email: suqiangqian@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: No. 10 Lymph Node Dissection group; 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	Procedure: laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the incidence of postoperative complications within 30 days	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
3-year disease free survival	36 months

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: October 8, 2018
• First Submitted That Met QC Criteria: October 14, 2018
• First Posted (Actual): October 17, 2018

Study Record Updates

• Last Update Posted (Actual): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 17, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: CFH2018-2-2153

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