Robotic Total Gastrectomy for Locally Advanced Proximal Gastric Cancer

NCT ID: NCT03524287

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2020-03-10

Brief Summary

The purpose of this study is to explore the clinical Efficacy of robotic assisted spleen-preserving No. 10 lymph node dissection for patients with locally advanced upper third gastric adenocarcinoma（cT2-4a, N-/+, M0）.

Detailed Description

The incidence of No. 10 lymph node metastasis is high in advanced proximal gastric cancer, reported to range from 9.8%-20.9%, and the presence of No. 10 lymph node metastasis is closely related to survival. Therefore, in East Asia, D2 lymph node dissection of potentially curable locally advanced upper third gastric cancer including No. 10 lymph node is the standard surgical treatment.

Robotic surgery has been developed with the aim of improving surgical quality and overcoming the limitations of conventional laparoscopy in the performance of complex mini-invasive procedures. However, it remains a controversial international issue if it is safe and feasible to conduct robotic assisted spleen-preserving No. 10 lymph node dissection for advanced upper third gastric cancer. There is no prospective study to identify the results.

The study is through a prospective, open, single-arm study,to explore the clinical outcomes of the robotic assisted spleen-preserving No. 10 lymph node dissection in the treatment of locally advanced gastric adenocarcinoma （cT2-4a, N-/+, M0）.

Conditions

Stomach Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No.10 lymph node dissections

Patients with locally advanced upper third gastric carcinoma will performed robotic assisted spleen-preserving No.10 lymph node dissections. After the surgery the patients will be treated with oxaliplatin or platinum-based chemotherapy.

Group Type: EXPERIMENTAL

Robotic Assisted No.10 Lymph Node Dissections

Intervention Type: PROCEDURE

After exclusion of T4b, bulky lymph nodes, or distant metastasis case et al. Robotic assisted spleen-preserving No.10 lymph node dissections will be performed with curative treated intent in patients with locally advanced upper third gastric adenocarcinoma

Interventions

Robotic Assisted No.10 Lymph Node Dissections

After exclusion of T4b, bulky lymph nodes, or distant metastasis case et al. Robotic assisted spleen-preserving No.10 lymph node dissections will be performed with curative treated intent in patients with locally advanced upper third gastric adenocarcinoma

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age between 18 to 75 years old
• Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
• Locally advanced tumor in the upper third or middle third of stomach without invading the greater curvature (cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC (American Joint Committee on Cancer) Cancer Staging Manual Seventh Edition)
• No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
• Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
• ASA (American Society of Anesthesiology) class I to III
• Written informed consent

Exclusion Criteria

• Pregnant and lactating women
• Suffering from severe mental disorder
• History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
• History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal --Dissection/Endoscopic Mucosal Resection )for gastric cancer)
• Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging including enlarged or bulky No.10 lymph node
• History of other malignant disease within the past 5 years
• History of previous neoadjuvant chemotherapy or radiotherapy
• History of unstable angina or myocardial infarction within the past 6 months
• History of cerebrovascular accident within the past 6 months
• History of continuous systematic administration of corticosteroids within 1 month
• Requirement of simultaneous surgery for other disease
• Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
• FEV1<50% of the predicted values
• Splenectomy must be performed due to the obvious tumor invasion in spleen or spleen blood vessels.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Medical University

OTHER

Sponsor Role: lead

Responsible Party

Chang-Ming Huang, Prof.

Director, Head of gastric surgery, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Changming Huang

Role: PRINCIPAL_INVESTIGATOR

Fujian Medical University Union Hospital

Locations

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Countries

China

References

Zhong Q, Zhang ZQ, Yan YQ, Li YF, He QC, Zheng CH, Chen QY, Huang CM. [Long-term oncological safety of robotic total gastrectomy for locally advanced proximal gastric cancer: a 5-year noninferiority comparison based on the FUGES-014 study]. Zhonghua Wei Chang Wai Ke Za Zhi. 2025 Aug 25;28(8):886-894. doi: 10.3760/cma.j.cn441530-20250610-00218. Chinese.

Reference Type: DERIVED

PMID: 40850834 (View on PubMed)

Other Identifiers

FUGES-014

Identifier Type: -

Identifier Source: org_study_id