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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02902575
Other study ID # FUGES-05
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2016
Est. completion date November 30, 2019

Study information

Verified date January 2021
Source Fujian Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to explore the safety, feasibility, long-term and oncologicaloutcomes of laparoscopic-assisted gastrectomy for advanced Gastric Cancer after neoadjuvant chemotherapy.


Description:

A prospective single-arm study designed to further evaluate laparoscopic-assisted gastrectomy for advanced Gastric Cancer after neoadjuvant chemotherapy will be performed, to evaluate the safety, feasibility, long-term and oncological outcomes. The evaluation parameters are perioperative mobility and mortality, perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date November 30, 2019
Est. primary completion date October 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Age from 18 to 75 years - Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy - cT2-4aN+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, previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection) - History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection - History of other malignant disease within past five years - 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Laparoscopic-assisted gastrectomy with D2 lymphadenectomy
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic-assisted gastrectomy with D2 lymphadenectomy will be performed with curative treated intent.The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fujian Medical University

Outcome

Type Measure Description Time frame Safety issue
Primary Morbidity The early postoperative complication are defined as the event observed within 30 days after surgery.Postoperative complications were graded according to the Clavien-Dindo classi?cation system 30 days
Secondary Pathological response Pathological response grading was performed according to the Becker TRG system 30 days
Secondary Radiological response Radiological response and progression were assessed according to RECIST version 1.1 30 days
Secondary 3-year disease free survival rate 3-year disease free survival rate 36 months
Secondary 3-year overall survival rate 3-year overall survival rate 36 months
Secondary 3-year recurrence pattern Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type 36 months
Secondary Mortality The early mortality are defined as the event observed within 30 days after surgery. 30 days
Secondary Time to first ambulation The data of postoperative recovery course 10 days
Secondary Rates of combined organ resection Combined organ resection performing by severe injury or abdominal adhesions 1 day
Secondary The number of lymph node dissection The number of lymph node dissection 1 day
Secondary The variation of weight The variation of weight on postoperative 3, 6, 9 and 12 months 12 months
Secondary The daily highest body temperature The daily highest body temperature before discharge 7 days
Secondary Time to first flatus Time to first flatus 10 days
Secondary Time to first liquid diet Time to first liquid diet 10 days
Secondary Time to soft diet Time to soft diet 10 days
Secondary Scale the amount of abdominal drainage Scale the amount of abdominal drainage 10 days
Secondary Blood transfusion Blood transfusion 10 days
Secondary The number of positive lymph nodes The number of positive lymph nodes 1 days
Secondary Intraoperative lymph node dissection time intraoperative lymph node dissection time includes infrapyloric area lymph node,suprapancreatic area lymph node,splenic hilar area lymph node, cardial area lymph node and jejunal lymph nodes adjacent to the anastomosis. 1 days
Secondary Intraoperative blood loss Intraoperative blood loss 1 days
Secondary Time of operation Time of operation 1 day
Secondary Intraoperative injury Intraoperative injury 1 days
Secondary The amount of use of titanium clip The amount of use of titanium clip 1 days
Secondary The rate of conversion to laparotomy The rate of conversion to laparotomy 1 days
Secondary The variation of albumin The variation of albumin on postoperative 3, 6, 9 and 12 months 12 month
Secondary The results of endoscopy the results of endoscopy on postoperative 3 and 12 months 12 month
Secondary The values of white blood cell count the values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded 7 days
Secondary The values of hemoglobin the values of hemoglobin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded. 7 days
Secondary The values of C-reactive protein the values of C-reactive protein from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded. 7 days
Secondary The values of prealbumin the values of prealbumin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded. 7 days
Secondary Duration of hospital stay Duration of hospital stay 10 days
Secondary Late postoperative complication The late postoperative complication was defined as the event observed within the period from postoperative day 31th to the end of month 36th. 36 months
Secondary Adverse events Adverse events (AEs) of neoadjuvant chemotherapy were assessed at each visit per the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0) 30 days
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