NCT02219854

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
178

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 14, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 19, 2014

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

March 5, 2019

Status Verified

March 1, 2019

Enrollment Period

5.4 years

First QC Date

August 14, 2014

Last Update Submit

March 4, 2019

Conditions

Stomach Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 3-year disease free survival rate

    36 months

Secondary Outcomes (7)

  • Morbidity

    30 days

  • 3-year overall survival rate

    36 months

  • 3-year recurrence pattern

    36 months

  • Mortality

    30 days

  • Morbidity

    36 months

  • +2 more secondary outcomes

Study Arms (2)

Laparoscopic gastrectomy

EXPERIMENTAL

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

Procedure: Laparoscopic gastrectomy

Open gastrectomy

ACTIVE COMPARATOR

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

Procedure: Open gastrectomy

Interventions

Laparoscopic gastrectomyPROCEDURE
Laparoscopic gastrectomy
Open gastrectomyPROCEDURE
Open gastrectomy

Eligibility Criteria

Age19 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Hongbo Wei, M.D. Ph.D.

CONTACT

+86-189-2210-2969drweihb@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of surgery

Study Record Dates

First Submitted

August 14, 2014

First Posted

August 19, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2019

Study Completion

July 1, 2020

Last Updated

March 5, 2019

Record last verified: 2019-03

Locations

CN(1)