The Safety and Feasibility of Laparoscopic-assisted Gastrectomy for Advanced Gastric Cancer After Neoadjuvant Chemotherapy

Stomach Neoplasms Clinical Trial

Official title:

The Safety and Feasibility of Laparoscopic-assisted Gastrectomy for Advanced Gastric Cancer After Neoadjuvant Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02902575
• Other study ID #: FUGES-05
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Stomach Neoplasms

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