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

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02219854

Collaborator

(none)

178

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stomach Neoplasms	Procedure: Laparoscopic gastrectomy Procedure: Open gastrectomy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

178 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Jul 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Jul 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Laparoscopic gastrectomy Laparoscopic distal subtotal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.	Procedure: Laparoscopic gastrectomy
Active Comparator: Open gastrectomy Open distal subtotal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.	Procedure: Open gastrectomy

Arm

Intervention/Treatment

Experimental: Laparoscopic gastrectomy

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

Procedure: Laparoscopic gastrectomy

Active Comparator: Open gastrectomy

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

Procedure: Open gastrectomy

Outcome Measures

Primary Outcome Measures

3-year disease free survival rate [36 months]

Secondary Outcome Measures

Morbidity [30 days]
3-year overall survival rate [36 months]
3-year recurrence pattern [36 months]
Mortality [30 days]
Morbidity [36 months]
Mortality [36 months]
Postoperative recovery situation [10 days]
Time to first ambulation, flatus, liquid diet, soft diet and duration of hospital stay are used to assess the postoperative recovery situation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 74 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong	China	510630

Sponsors and Collaborators

Third Affiliated Hospital, Sun Yat-Sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hongbo Wei, Chief of surgery, Third Affiliated Hospital, Sun Yat-Sen University

ClinicalTrials.gov Identifier:

NCT02219854

Other Study ID Numbers:

LASS-01

First Posted:

Aug 19, 2014

Last Update Posted:

Mar 5, 2019

Last Verified:

Mar 1, 2019

Additional relevant MeSH terms:

Stomach Neoplasms

Study Results

No Results Posted as of Mar 5, 2019