The Effect of Preoperative Hemotologic Markers on Postoperative Long-term and Short-term Outcomes for Laparoscopic Gastrectomy

NCT02930278 | Unknown DMC

• 1 other identifier: 2016YF016-02
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore the effect of preoperative hemotologic markers on postoperative long-term and short-term outcomes for laparoscopic gastrectomy.

Conditions

Stomach Neoplasms

Outcome Measures

Primary Outcomes (1)

• 3-year disease overall survival rate

  36 months

Secondary Outcomes (29)

• overall postoperative morbidity rates

  30 days

• 3-year disease free survival rate

  36 months

• 3-year recurrence pattern

  36 months

• Time to first ambulation

  10 days

• The number of lymph node dissection

  1 day

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who undergoing laparoscopic radical gastrectomy for gastric cancer are included.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Changming Huang, Professor

  Fujian Medical University Union Hospital,China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: October 12, 2016
• Study Start: September 1, 2016
• Primary Completion: October 30, 2017
• Study Completion: September 1, 2020
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)