NCT02789891

Brief Summary

The purpose of this study is to explore the short-term, long-term and oncological outcomes of laparoscopic No. 14v lymph node dissection in advanced lower third gastric cancer.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
326

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

May 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2016

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

5.5 years

First QC Date

May 29, 2016

Last Update Submit

February 4, 2020

Conditions

Stomach Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 3-year disease overall survival rate

    36 months

Secondary Outcomes (30)

  • No.14v Lymph node metastasis rate

    10 days

  • Morbidity and mortality

    30 days; 36 months

  • 3-year free survival rate

    36 months

  • 3-year recurrence pattern

    36 months

  • Time to first ambulation

    10 days

  • +25 more secondary outcomes

Study Arms (2)

D2 Lymphadenectomy including No. 14v

EXPERIMENTAL

Laparoscopic distal gastrectomy with D2 lymphadenectomy including No. 14v lymph node dissection will be performed for the treatment of patients assigned to this group

Procedure: D2 lymphadenectomy including No. 14v

D2 lymphadenectomy excluding No. 14v

ACTIVE COMPARATOR

Laparoscopic distal gastrectomy with D2 lymphadenectomy excluding No. 14v lymph node dissection will be performed for the treatment of patients assigned to this group

Procedure: lymphadenectomy excluding No. 14v

Interventions

D2 lymphadenectomy including No. 14vPROCEDURE

After exclusion of T4b, or distant metastasis case by diagnostic laparoscopy, Laparoscopic distal with D2 lymphadenectomy including No. 14v Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience

D2 Lymphadenectomy including No. 14v
lymphadenectomy excluding No. 14vPROCEDURE

After exclusion of T4b, or distant metastasis case by diagnostic laparoscopy, Laparoscopic distal gastrectomy with D2 lymphadenectomy excluding No. 14v Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience

D2 lymphadenectomy excluding No. 14v

Eligibility Criteria

Age10 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Primary lower third 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 American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
  • No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
  • Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
  • American Society of Anesthesiology score (ASA) class I, II, or III
  • Written informed consent

You may not qualify if:

  • 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 envelop important vessels
  • 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

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

May 29, 2016

First Posted

June 3, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2021

Study Completion

January 1, 2024

Last Updated

February 5, 2020

Record last verified: 2020-02