Trials Comparing of HD Versus 4K Laparoscopy for Gastric Cancer

Stomach Neoplasms Clinical Trial

Official title:

Randomized Controlled Trials Comparing Clinical Outcome of HD Versus 4K Laparoscopy for Gastric Cancer(FUGES-017)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04010006
• Other study ID #: FUGES-017
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: July 15, 2023

Study information

• Verified date: January 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 feasibility of 4K Laparoscopic Surgery for Gastric Cancer.

Description:

A prospective randomized comparison of HD and 4K laparoscopic surgery for gastric cancer will be performed, to evaluate the clinical value and provide theoretical basis and clinical experience for the extensive application of the 4K laparoscopic technique. 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: 502
• Est. completion date: July 15, 2023
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 74 Years

Eligibility

Inclusion Criteria:

• (1)Age from over 19 to under 74 years

• (2)cT 1-4a(clinical stage tumor), N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition

• (3)Heart, lungs, kidneys and other vital organs function well, with no obvious surgical contraindications

• (4)Preoperative examination with no distant metastasis, no significantly enlarged lymph nodes around abdominal main artery, and tumor not a direct violation of the pancreas, spleen and other surrounding organs

• (5)American Society of Anesthesiology (ASA) score class I, II, or III

• (6)Written informed consent

Exclusion Criteria:

• (1)Women during pregnancy or breast-feeding

• (2)Severe mental disorder

• (3)History of previous upper abdominal surgery (except laparoscopic cholecystectomy)

• (4)Enlarged splenic hilar lymph nodes with integration into a mass and surrounding the blood vessels

• (5)History of unstable angina or myocardial infarction within past six months

• (6)History of cerebrovascular accident within past six months

• (7)History of continuous systematic administration of corticosteroids within one month

• (8)History of previous neoadjuvant chemotherapy or radiotherapy

• (9)T4b tumors

• (10)Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer

• (11)FEV1(Forced expiratory volume in one second)#50% of predicted values

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Procedure:
• 4K Laparoscopic Surgery
4K Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.
• HD Laparoscopic Surgery
HD Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operating time	day	1 day
Secondary	The number of lymph node dissection	number	1 day
Secondary	the number of positive lymph nodes	the number of positive lymph nodes	1 day
Secondary	intraoperative lymph node dissection time	(regional analysis:infrapyloric area lymph node,suprapancreatic area lymph node,splenic hilar area lymph node,cardial area lymph node)	1 day
Secondary	intracavitary anastomosis time	(patients who undergo totally laparoscopic surgery are analyzed)	1 day
Secondary	intraoperative blood loss	ml	1 day
Secondary	intraoperative injury	intraoperative injury	1 day
Secondary	the amount of use of titanium clip	the amount of use of titanium clip	1 day
Secondary	the rate of conversion to laparotomy	the rate of conversion to laparotomy	1 day
Secondary	Time to first ambulation	Time to first ambulation	10 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 first soft diet	Time to first soft diet	10 days
Secondary	duration of postoperative hospital stay	duration of postoperative hospital stay	10 days
Secondary	Complication	(early complications occurred within 30 days after operation): pulmonary infection, incision complication, intestinal obstruction, abdominal infection, anastomotic bleeding, anastomotic fistula, gastric emptying; long term complications (30 days later after operation): anastomotic stenosis, intestinal obstruction, dumping syndrome	30 days;36 months
Secondary	The daily highest body temperature before discharge	The daily highest body temperature before discharge	7 days
Secondary	Overall postoperative morbidity and mortality rates	The number of all patients treated with surgery as the denominator and the number of the patients with any intraoperative and postoperative morbidity and mortality as the numerator are used to calculate the proportions.; Postoperative morbidities are divided into short-term and long-term complications after surgery.; Short-term is defined as within 30 days of surgery or the first discharge if the hospital stay is > 30 days.; Long-term is defined as the period from 30 days or more after the operation or the period between first discharge (the hospital days after surgery >30 days) and 3 years after the operation.; Postoperative mortality: patients whose death was identified according to documented intraoperative observation items, including patients who die within 30 days after surgery (including the 30th day) regardless of the causality between death and surgery, and patients who die more than 30 days after surgery.	30 days
Secondary	Hospitalization expenses	dolloars	1 months
Secondary	3-year disease free survival rate	month	36 months
Secondary	3-year overall survival rate	month	36 months