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

NCT ID: NCT02219854

Last Updated: 2019-03-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2020-07-31

Brief 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.

Conditions

Stomach Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laparoscopic gastrectomy

Laparoscopic distal subtotal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.

Group Type: EXPERIMENTAL

Laparoscopic gastrectomy

Intervention Type: PROCEDURE

Open gastrectomy

Open distal subtotal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.

Group Type: ACTIVE_COMPARATOR

Open gastrectomy

Intervention Type: PROCEDURE

Interventions

Laparoscopic gastrectomy

Intervention Type: PROCEDURE

Open gastrectomy

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Hongbo Wei

Chief of surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hongbo Wei, M.D. Ph.D.

Role: CONTACT

drweihb@126.com

+86-189-2210-2969

Facility Contacts

Hongbo Wei, M.D., Ph.D.

Role: primary

8613760660785

Other Identifiers

LASS-01

Identifier Type: -

Identifier Source: org_study_id