Randomized Controlled Trials on Laparoscopic No. 14v LNS Dissection

Stomach Neoplasms Clinical Trial

Official title:

Randomized Controlled Trials on Laparoscopic No. 14v Lymph Node Dissection for Advanced Lower Third Gastric Cancer

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02789891
• Other study ID #: 2016-03
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 2016
• Est. completion date: January 2024

Study information

• Verified date: February 2020
• 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 short-term, long-term and oncological outcomes of laparoscopic No. 14v lymph node dissection in advanced lower third gastric cancer.

Description:

A prospective randomized comparison of laparoscopic No. 14v lymph node dissection in advanced lower third 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 326
• Est. completion date: January 2024
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 75 Years

Eligibility

Inclusion Criteria:• 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

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 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

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Procedure:
• D2 lymphadenectomy including No. 14v
After exclusion of T4b, or distant metastasis case by diagnostic laparoscopy, Laparoscopic distal with D2 lymphadenectomy including No. 14v Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience
• lymphadenectomy excluding No. 14v
After exclusion of T4b, or distant metastasis case by diagnostic laparoscopy, Laparoscopic distal gastrectomy with D2 lymphadenectomy excluding No. 14v Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year disease overall survival rate		36 months
Secondary	No.14v Lymph node metastasis rate		10 days
Secondary	Morbidity and mortality	The early postoperative complication and mortality are defined as the event observed within 30 days after surgery, while the time frame for late complication is the period from postoperative day 31th to the end of month 36th.	30 days; 36 months
Secondary	3-year free 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	Time to first ambulation	The data of postoperative recovery course.	10 days
Secondary	The number of lymph node dissection		10day
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 day
Secondary	Time to first flatus		10 days
Secondary	Time to first liquid diet		10 days
Secondary	Time to soft diet		10 days
Secondary	Duration of hospital stay		10 days
Secondary	The amount of abdominal drainage		10 days
Secondary	Blood transfusion		10 days
Secondary	The number of positive lymph nodes		1 day
Secondary	Intraoperative lymph node dissection time	intraoperative No.14v lymph node dissection time includes infrapyloric area lymph node,suprapancreatic area lymph node,splenic hilar area lymph node, cardial area lymph node	1 day
Secondary	Intraoperative blood loss		1 day
Secondary	Intraoperative injury		1 day
Secondary	The amount of use of titanium clip		1 day
Secondary	The rate of conversion to laparotomy		1 day
Secondary	The variation of cholesterol	The variation of cholesterol on postoperative 3, 6, 9 and 12 months	12 months
Secondary	The variation of albumin	The variation of albumin on postoperative 3, 6, 9 and 12 months	12 months
Secondary	The results of endoscopy	the results of endoscopy on postoperative 3 and 12 months	12 months
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	and 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	and 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	and the values of prealbumin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.	7 days
Secondary	The values of relevant immune cytokines	and the values of relevant immune cytokines including T cell percentage, T-helper lymphocytes (CD4+) percentage, T-suppressor lymphocytes (CD8+) percentage, natural killer (NK) cells percentage from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.	7 days
Secondary	Visual Analog Score for pain	the values of visual analog score for pain before operation and on postoperative day 1 to day 7 are recorded.	7 days
Secondary	EORTC QLQ-C30 and QLQ - STO22	European Organization fo Research and Treatment(EORTC) QLQ-C30 and QLQ - STO22 before operation and on postoperative month 6,12,36 are recorded.	Time Frame: 36 months