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

Esophagogastric Junction Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04153058
• Other study ID #: FUGES-018
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: October 2025

Study information

• Verified date: February 2020
• Source: Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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）

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: October 2025
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophagogastric Junction Adenocarcinoma

Intervention

Procedure:
• Robotic Assisted AEG Radical Gastrectomy
Robotic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma
• Laparoscopic Assisted AEG Radical Gastrectomy
Laparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year disease free survival rate	3-year disease free survival rate	36 months
Secondary	3-year overall survival rate	3-year overall survival rate	36 months
Secondary	3-year recurrence pattern	3-year recurrence pattern	36 months
Secondary	overall postoperative morbidity rates	overall postoperative morbidity rates	30 days
Secondary	intraoperative morbidity rates	intraoperative morbidity rates	1 day
Secondary	overall postoperative serious morbidity rates	overall postoperative serious morbidity rates	30 days
Secondary	number of retrieved lymph nodes	number of retrieved lymph nodes	14 days
Secondary	Time to first ambulation	Time to first ambulation is used to access the postoperative recovery course.	30 days
Secondary	Time to first flatus	Time to first flatus is used to access the postoperative recovery course.	30 days
Secondary	Time to first liquid diet	Time to first liquid diet is used to access the postoperative recovery course.	30 days
Secondary	Time to soft diet	Time to soft diet is used to access the postoperative recovery course.	30 days
Secondary	Duration of hospital stay	Duration of hospital stay is used to access the postoperative recovery course.	30 days
Secondary	The amount of abdominal drainageare	The amount of abdominal drainageare is used to access the postoperative recovery course.	30 days
Secondary	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
Secondary	Hospitalization costs	Hospitalization costs	30 days