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Clinical Trials/NCT02333721
NCT02333721UnknownNot Applicable

Study on Long-term Outcome of Laparoscopic Spleen-Preserving D2 Lymphadenectomy With and Without No. 10 Lymph Node Dissection for Advanced Gastric Cancer

Fujian Medical University1 site in 1 country536 target enrollmentStarted: January 2015Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
536
Locations
1
Primary Endpoint
3-year disease free survival rate
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to explore the short-term, long-term and oncological outcomes of laparoscopic spleen-preserving No. 10 lymph node dissection in a left-sided approach for advanced middle or upper third gastric cancer not invading greater curvature.

Detailed Description

A prospective randomized comparison of laparoscopic spleen-preserving No. 10 lymph node dissection for 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
10 Years to 75 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age from 18 to 75 years
  • •Primary proximal gastric adenocarcinoma not invading greater curvature (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 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

Outcomes

Primary Outcomes

3-year disease free survival rate

Time Frame: 36 months

Secondary Outcomes

  • Blood transfusion(10 days)
  • Morbidity and mortality(30 days; 36 months)
  • 3-year overall survival rate(36 months)
  • 3-year recurrence pattern(36 months)
  • Time to first ambulation(10 days)
  • Rates of splenectomy(1 day)
  • Rates of injury to splenic vessels(1 day)
  • The number of lymph node dissection(1 day)
  • The variation of weight(12 months)
  • The amount of abdominal drainage(10 days)
  • The daily highest body temperature(7 days)
  • Time to first flatus(10 days)
  • Time to first liquid diet(10 days)
  • Time to soft diet(10 days)
  • Duration of hospital stay(10 days)
  • The number of positive lymph nodes(1 day)
  • Intraoperative lymph node dissection time(1 day)
  • Intraoperative blood loss(1 day)
  • Intraoperative injury(1 day)
  • The amount of use of titanium clip(1 day)
  • The rate of conversion to laparotomy(1 day)
  • The variation of cholesterol(12 months)
  • The variation of albumin(12 months)
  • The results of endoscopy(12 months)
  • The values of white blood cell count(7 days)
  • The values of hemoglobin(7 days)
  • The values of C-reactive protein(7 days)
  • The values of prealbumin(7 days)
  • The values of relevant immune cytokines(7 days)
  • The Surgery Task Load Index (SURG-TLX)(1 days)
  • Lymph node noncompliance rate(1 days)
  • Technical performance(1 days)

Investigators

Sponsor
Fujian Medical University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chang-Ming Huang, Prof.

Director, Principal Investigator, Clinical Professor

Fujian Medical University Union Hospital

Study Sites (1)

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