Single-center Study on Laparoscopic Distal Subtotal Gastrectomy for Advanced Gastric Cancer

Stomach Neoplasms Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02219854
• Other study ID #: LASS-01
• Status: Recruiting
• Phase: N/A
• Start date: July 2014
• Est. completion date: July 2020

Study information

• Verified date: March 2019
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Hongbo Wei, M.D. Ph.D.
• Phone: +86-189-2210-2969
• Email: drweihb[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Laparoscopic distal subtotal gastrectomy with lymph node dissection for treatment of gastric cancer is popular in East Asian countries. However, the long-term follow-up outcome based on randomized clinical trial (RCT) is still rare. Some studies indicated that laparoscopic distal subtotal gastrectomy with D2 lymphadenectomy is a technically feasible and safe procedure by experienced surgeons in high-volume specialized hospitals. However, the application of it is still limited because of lack of solid evidence on the oncologic efficacy. Nowadays, the proportion of patients with locally advanced gastric cancer is estimated up to 80 percent of all gastric cancer cases in China. Before the clinical application of laparoscopic procedure for the treatment with curative intent to advanced gastric cancer located at the middle- or lower-third of the stomach, the oncologic efficacy must be verified.Accordingly, the comparison of long-term outcome between laparoscopic and open distal subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer based on a well designed RCT is needed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 178
• Est. completion date: July 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 74 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, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition Expected curative resection through distal subtotal gastrectomy with D2 lymphadenectomy Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale ASA (American Society of Anesthesiology) score 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

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Procedure:
• Laparoscopic gastrectomy

• Open gastrectomy

Locations

Country	Name	City	State
China	The Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year disease free survival rate		36 months
Secondary	Morbidity		30 days
Secondary	3-year overall survival rate		36 months
Secondary	3-year recurrence pattern		36 months
Secondary	Mortality		30 days
Secondary	Morbidity		36 months
Secondary	Mortality		36 months
Secondary	Postoperative recovery situation	Time to first ambulation, flatus, liquid diet, soft diet and duration of hospital stay are used to assess the postoperative recovery situation.	10 days