ClinicalTrials.Veeva

Menu

Randomized Controlled Trials on Laparoscopic No. 14v LNS Dissection

F

Fujian Medical University

Status

Unknown

Conditions

Stomach Neoplasms

Treatments

Procedure: lymphadenectomy excluding No. 14v
Procedure: D2 lymphadenectomy including No. 14v

Study type

Interventional

Funder types

Other

Identifiers

NCT02789891
2016-03

Details and patient eligibility

About

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.

Full description

A prospective randomized comparison of laparoscopic No. 14v lymph node dissection in advanced lower third gastric cancer will be performed, to evaluate the short-term, long-term and oncological outcomes. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.

Enrollment

326 estimated patients

Sex

All

Ages

10 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:• Age from 18 to 75 years

  • 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

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 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

326 participants in 2 patient groups

D2 Lymphadenectomy including No. 14v
Experimental group
Description:
Laparoscopic distal gastrectomy with D2 lymphadenectomy including No. 14v lymph node dissection will be performed for the treatment of patients assigned to this group
Treatment:
Procedure: D2 lymphadenectomy including No. 14v
D2 lymphadenectomy excluding No. 14v
Active Comparator group
Description:
Laparoscopic distal gastrectomy with D2 lymphadenectomy excluding No. 14v lymph node dissection will be performed for the treatment of patients assigned to this group
Treatment:
Procedure: lymphadenectomy excluding No. 14v

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems