Trials Comparing of HD Versus 4K Laparoscopy for Gastric Cancer

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

The purpose of this study is to explore the feasibility of 4K Laparoscopic Surgery for Gastric Cancer.

Study Overview

• Status: Enrolling by invitation
• Conditions: Stomach Neoplasms
• Intervention / Treatment: Procedure: 4K Laparoscopic Surgery; Procedure: HD Laparoscopic Surgery

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 502
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350000
      • Fujian Medical University Union Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 4K Laparoscopic Surgery; 4K Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.	Procedure: 4K Laparoscopic Surgery; 4K Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.
Active Comparator: HD Laparoscopic Surgery; HD Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.	Procedure: HD Laparoscopic Surgery; HD Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operating time	day	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the rate of conversion to laparotomy	the rate of conversion to laparotomy	1 day
The number of lymph node dissection	number	1 day
the number of positive lymph nodes	the number of positive lymph nodes	1 day
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
intracavitary anastomosis time	(patients who undergo totally laparoscopic surgery are analyzed)	1 day
intraoperative blood loss	ml	1 day
intraoperative injury	intraoperative injury	1 day
the amount of use of titanium clip	the amount of use of titanium clip	1 day
Time to first ambulation	Time to first ambulation	10 days
Time to first flatus	Time to first flatus	10 days
Time to first liquid diet	Time to first liquid diet	10 days
Time to first soft diet	Time to first soft diet	10 days
duration of postoperative hospital stay	duration of postoperative hospital stay	10 days
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
The daily highest body temperature before discharge	The daily highest body temperature before discharge	7 days
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
Hospitalization expenses	dolloars	1 months
3-year disease free survival rate	month	36 months
3-year overall survival rate	month	36 months

Collaborators and Investigators

• Sponsor: Fujian Medical University
• Investigators: Study Chair: Changming Huang Huang, Fujian Medical University Union Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Anticipated): July 15, 2020
• Study Completion (Anticipated): July 15, 2023

Study Registration Dates

• First Submitted: May 9, 2019
• First Submitted That Met QC Criteria: July 2, 2019
• First Posted (Actual): July 8, 2019

Study Record Updates

• Last Update Posted (Actual): January 7, 2020
• Last Update Submitted That Met QC Criteria: January 3, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Laparoscopy; Stomach Neoplasms
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: FUGES-017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No