Robotic Total Gastrectomy for Locally Advanced Proximal Gastric Cancer

Stomach Neoplasms Clinical Trial

Official title:

Clinical Efficacy of Robotic Total Gastrectomy With D2 Lymph Node Dissection for Locally Advanced Proximal Gastric Cancer：A Prospective Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03524287
• Other study ID #: FUGES-014
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: March 10, 2020

Study information

• Verified date: September 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 Efficacy of robotic assisted spleen-preserving No. 10 lymph node dissection for patients with locally advanced upper third gastric adenocarcinoma（cT2-4a, N-/+, M0）.

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）.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 10, 2020
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Procedure:
• 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

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	overall postoperative morbidity rates	Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery	30 days
Secondary	Numbers of No.10 lymph node dissection	Numbers of dissected No.10 lymph nodes	9 days
Secondary	Rates of positive No.10 lymph node	The Rates of positive No.10 lymph node are defined as the incidence of positive No.10 lymph node (divide number of positive No.10 lymph nodes by number of total No.10 lymph nodes)	9 days
Secondary	3-year overall survival rate	3-year overall survival rate	36 months
Secondary	3-year disease free survival rate	3-year disease free survival rate	36 months
Secondary	3-year recurrence pattern	Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type	36 months
Secondary	Rates of splenectomy	The Rates of splenectomy are defined as the incidence of splenectomy within operation.	1 days
Secondary	Intraoperative morbidity rates	The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.	1 days
Secondary	Time to first ambulation	Time to first ambulation in hours is used to assess the postoperative recovery course.	30 days
Secondary	Time to first flatus	Time to first flatus in days is used to assess the postoperative recovery course.	30 days
Secondary	Time to first liquid diet	Time to first liquid diet in days is used to assess the postoperative recovery course.	30 days
Secondary	Time to first soft diet	Time to first soft diet in days is used to assess the postoperative recovery course.	30 days
Secondary	Duration of postoperative hospital stay	Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.	30 days
Secondary	The variation of weight	The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.	3, 6, 9 and 12 months
Secondary	The variation of album	The variation of album in gram/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.	3, 6, 9 and 12 months
Secondary	The variation of white blood cell count	The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.	Preoperative 3 days and postoperative 1, 3, and 5 days
Secondary	The variation of C-reactive protein	The values of C-reactive protein IN milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.	Preoperative 3 days and postoperative 1, 3, and 5 days
Secondary	Technical performance	Technical performance were assessed by the Objective Structured Assessments of Technical Skills (OSATS) and the Generic Error Rating Tool.	1 days
Secondary	The Surgery Task Load Index (SURG-TLX)	Surgeons were required to complete one modified SURG-TLX questionnaire for each procedure.	1 days
Secondary	Lymph node noncompliance rate	Lymph node noncompliance was defined as the absence of lymph nodes that should have been excised from more than 1 lymph node station. Major lymph node noncompliance was defined as more than 2 intended lymph node stations that were not removed.	1 days