Study on Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Advanced Middle or Upper Third Gastric Cancer (LSPLN)

Fujian Medical University

Status: Unknown

Conditions: Stomach Neoplasms

Treatments: Procedure: D2 lymphadenectomy excluding No. 10; Procedure: D2 lymphadenectomy including No. 10

Study type: Interventional

Funder types: Other

Identifiers

NCT02333721

FUGES-002

Details and patient eligibility

About

The purpose of this study is to explore the short-term, long-term and oncological outcomes of laparoscopic spleen-preserving No. 10 lymph node dissection in a left-sided approach for advanced middle or upper third gastric cancer not invading greater curvature.

Full description

A prospective randomized comparison of laparoscopic spleen-preserving No. 10 lymph node dissection for gastric cancer will be performed, to evaluate the short-term, long-term and oncological outcomes. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.

Enrollment: 536 estimated patients

Sex: All

Ages: 10 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age from 18 to 75 years
• Primary proximal gastric adenocarcinoma not invading greater curvature (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
• cT2-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
• No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
• Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
• American Society of Anesthesiology score (ASA) class I, II, or III
• Written informed consent

Exclusion criteria

• Women during pregnancy or breast-feeding
• Severe mental disorder
• History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
• History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
• Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
• History of other malignant disease within past five years
• History of previous neoadjuvant chemotherapy or radiotherapy
• History of unstable angina or myocardial infarction within past six months
• History of cerebrovascular accident within past six months
• History of continuous systematic administration of corticosteroids within one month
• Requirement of simultaneous surgery for other disease
• Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
• FEV1<50% of predicted values

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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536 participants in 2 patient groups

D2 Lymphadenectomy including No. 10

Experimental group

Description:

Laparoscopic total gastrectomy with D2 lymphadenectomy including spleen-preserving No. 10 lymph node dissection will be performed for the treatment of patients assigned to this group

Treatment:

Procedure: D2 lymphadenectomy including No. 10

D2 lymphadenectomy excluding No. 10

Active Comparator group

Description:

Laparoscopic total gastrectomy with D2 lymphadenectomy excluding spleen-preserving No. 10 lymph node dissection will be performed for the treatment of patients assigned to this group

Treatment:

Procedure: D2 lymphadenectomy excluding No. 10