Clinical Outcomes of Robotic Versus Laparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III AEG

Randomized Controlled Trials on Clinical Outcomes of Robotic Versus Laparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma

The purpose of this study is to explore the clinical outcomes of the robotic assisted radical gastrectomy for advanced Siewert II/III esophagogastric junction adenocarcinoma（cT2-4a, N-/+, M0）

Study Overview

• Status: Enrolling by invitation
• Conditions: Esophagogastric Junction Adenocarcinoma
• Intervention / Treatment: Procedure: Robotic Assisted AEG Radical Gastrectomy; Procedure: Laparoscopic Assisted AEG Radical Gastrectomy

Detailed Description

In recent years, the incidence of gastric cancer has been decreasing year by year in the world, but the incidence of adenocarcinoma of the esophagogastric junction (AEG) has shown a significant upward trend, especially in Western countries such as Europe and the United States. The prognosis of AEG is poor, therefore, it is extremely necessary to establish AEG's best diagnosis and treatment strategies to improve the long-term outcome of AEG. 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. The study is designed to explore the clinical outcomes of the robotic assisted radical gastrectomy for advanced Siewert II/III esophagogastric junction adenocarcinoma (cT2-4a, N-/+, M0) by comparing with laparoscopic assisted.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Medical University Union Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age from over 18 to under 75 years
• Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
• cT2-4a(clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
• Expected to perform total gastrectomy with D2+No.19+No.20 lymph node dissction to obtain R0 resection sugicall results.
• 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:

• Women during pregnancy or breast-feeding
• Severe mental disorder
• History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
• History of previous gastric surgery (except ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
• Gastric multiple primary carcinoma
• Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic Assisted AEG Radical Gastrectomy; Robotic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma	Procedure: Robotic Assisted AEG Radical Gastrectomy; Robotic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma
Active Comparator: Laparoscopic Assisted AEG Radical Gastrectomy; Laparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma	Procedure: Laparoscopic Assisted AEG Radical Gastrectomy; Laparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall postoperative morbidity rates	overall postoperative morbidity rates	30 days
3-year recurrence pattern	3-year recurrence pattern	36 months
overall postoperative serious morbidity rates	overall postoperative serious morbidity rates	30 days
3-year overall survival rate	3-year overall survival rate	36 months
intraoperative morbidity rates	intraoperative morbidity rates	1 day
number of retrieved lymph nodes	number of retrieved lymph nodes	14 days
Time to first ambulation	Time to first ambulation is used to access the postoperative recovery course.	30 days
Time to first flatus	Time to first flatus is used to access the postoperative recovery course.	30 days
Time to first liquid diet	Time to first liquid diet is used to access the postoperative recovery course.	30 days
Time to soft diet	Time to soft diet is used to access the postoperative recovery course.	30 days
Duration of hospital stay	Duration of hospital stay is used to access the postoperative recovery course.	30 days
The amount of abdominal drainageare	The amount of abdominal drainageare is used to access the postoperative recovery course.	30 days
postoperative nutritional status	Weight and height will be combined to report BMI in kg/m^2. The variation of BMI in kg/m^2 on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status.	3, 6, 9 and 12 months
Hospitalization costs	Hospitalization costs	30 days

Collaborators and Investigators

• Sponsor: Fujian Medical University
• Investigators: Principal Investigator: Chang-Ming Huang, Fujian Medical University Union Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2025

Study Registration Dates

• First Submitted: October 20, 2019
• First Submitted That Met QC Criteria: November 3, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: FUGES-018

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