Status:

UNKNOWN

Spleen-Preserving No. 10 Lymph Node Dissection in Gastric Cancer

Lead Sponsor:

Jian Suo

Conditions:

Overall Survival

Eligibility:

All Genders

18-80 years

Phase:

NA

Brief Summary

This study is to conduct a randomized controlled trial of two kinds of radical gastrectomy for patients with proximal gastric cancer. One is laparoscopic D2 radical total gastrectomy combined with spl...

Eligibility Criteria

Inclusion

  • Age from 18 to 80 years
  • Primary distal 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

  • 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

Key Trial Info

Start Date :

July 21 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2022

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT04050787

Start Date

July 21 2019

End Date

May 1 2022

Last Update

August 8 2019

Active Locations (1)

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1

First Hospital of Jilin University

Changchun, Jilin, China, 130021