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

• ClinicalTrials.gov Identifier: NCT03708783
• Recruitment Status: Recruiting
• First Posted: October 17, 2018
• Last Update Posted: November 19, 2019
• Sponsor: Beijing Cancer Hospital
• Information provided by (Responsible Party): Xiangqian Su, Beijing Cancer Hospital

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.

Condition or disease	Intervention/treatment	Phase
Gastric Cancer; Gastrectomy; Laparoscopic Surgery; Lymphadenectomy	Procedure: laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 170 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention 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)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: July 1, 2018
• Estimated Primary Completion Date: December 30, 2020
• Estimated Study Completion Date: December 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. the incidence of postoperative complications within 30 days [ Time Frame: 30 days ]

Secondary Outcome Measures :

1. 3-year disease free survival [ Time Frame: 36 months ]

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

Contact: Zaozao Wang; 0086-10-88196851; zaozao83630@sina.com

Locations

China, Beijing

Beijing Cancer Hospital; Recruiting

Beijing, Beijing, China, 100142

Contact: Xiangqian Su 0086-10-88196696 suqiangqian@bjmu.edu.cn

Sponsors and Collaborators

Beijing Cancer Hospital

More Information

• Responsible Party: Xiangqian Su, Chief of GI surgery IV, Beijing Cancer Hospital
• ClinicalTrials.gov Identifier: NCT03708783
• Other Study ID Numbers: CFH2018-2-2153
• First Posted: October 17, 2018
• Last Update Posted: November 19, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Stomach Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases