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

NCT03708783 | Unknown

• 1 other identifier: CFH2018-2-2153
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer; Gastrectomy; Laparoscopic Surgery; Lymphadenectomy

Outcome Measures

Primary Outcomes (1)

• the incidence of postoperative complications within 30 days

  30 days

Secondary Outcomes (1)

• 3-year disease free survival

  36 months

Study Arms (1)

No. 10 Lymph Node Dissection group

EXPERIMENTAL

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

Interventions

laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection PROCEDURE

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.

No. 10 Lymph Node Dissection group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Zaozao Wang

CONTACT

0086-10-88196851; zaozao83630@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of GI surgery IV

Model Details: Patients with locally advanced upper and middle third gastric cancer will receive laparoscopic total gastrectomy with D2 lymphadenectomy including No. 10 lymph node dissection.

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 17, 2018
• Study Start: July 1, 2018
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2023
• Last Updated: November 19, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)