Randomized Controlled Trials on Laparoscopic No. 14v LNS Dissection

NCT ID: NCT02789891

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

326 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2024-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stomach Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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D2 Lymphadenectomy including No. 14v

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

Group Type EXPERIMENTAL

D2 lymphadenectomy including No. 14v

Intervention Type PROCEDURE

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 excluding No. 14v

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

Group Type ACTIVE_COMPARATOR

lymphadenectomy excluding No. 14v

Intervention Type PROCEDURE

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

Interventions

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D2 lymphadenectomy including No. 14v

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

Intervention Type PROCEDURE

lymphadenectomy excluding No. 14v

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

* 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
Minimum Eligible Age

10 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Chang-Ming Huang, Prof.

Director, Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2016-03

Identifier Type: -

Identifier Source: org_study_id

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