Back to resultsTrials Comparing of HD Versus 4K Laparoscopy for Gastric Cancer
Primary Purpose
Stomach Neoplasms
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
4K Laparoscopic Surgery
HD Laparoscopic Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasms focused on measuring Stomach Neoplasms, Laparoscopy
Eligibility Criteria
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
Sites / Locations
- Fujian Medical University Union Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
4K Laparoscopic Surgery
HD Laparoscopic Surgery
Arm Description
4K Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.
HD Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.
Outcomes
Primary Outcome Measures
operating time
day
Secondary Outcome Measures
The number of lymph node dissection
number
the number of positive lymph nodes
the number of positive lymph nodes
intraoperative lymph node dissection time
(regional analysis:infrapyloric area lymph node,suprapancreatic area lymph node,splenic hilar area lymph node,cardial area lymph node)
intracavitary anastomosis time
(patients who undergo totally laparoscopic surgery are analyzed)
intraoperative blood loss
ml
intraoperative injury
intraoperative injury
the amount of use of titanium clip
the amount of use of titanium clip
the rate of conversion to laparotomy
the rate of conversion to laparotomy
Time to first ambulation
Time to first ambulation
Time to first flatus
Time to first flatus
Time to first liquid diet
Time to first liquid diet
Time to first soft diet
Time to first soft diet
duration of postoperative hospital stay
duration of postoperative hospital stay
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
The daily highest body temperature before discharge
The daily highest body temperature before discharge
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.
Hospitalization expenses
dolloars
3-year disease free survival rate
month
3-year overall survival rate
month
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04010006
Brief Title
Trials Comparing of HD Versus 4K Laparoscopy for Gastric Cancer
Official Title
Randomized Controlled Trials Comparing Clinical Outcome of HD Versus 4K Laparoscopy for Gastric Cancer(FUGES-017)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
July 15, 2020 (Anticipated)
Study Completion Date
July 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fujian Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to explore the feasibility of 4K Laparoscopic Surgery for Gastric Cancer.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
Keywords
Stomach Neoplasms, Laparoscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
502 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
4K Laparoscopic Surgery
Arm Type
Experimental
Arm Description
4K Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.
Arm Title
HD Laparoscopic Surgery
Arm Type
Active Comparator
Arm Description
HD Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.
Intervention Type
Procedure
Intervention Name(s)
4K Laparoscopic Surgery
Intervention Description
4K Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.
Intervention Type
Procedure
Intervention Name(s)
HD Laparoscopic Surgery
Intervention Description
HD Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.
Primary Outcome Measure Information:
Title
operating time
Description
day
Time Frame
1 day
Secondary Outcome Measure Information:
Title
The number of lymph node dissection
Description
number
Time Frame
1 day
Title
the number of positive lymph nodes
Description
the number of positive lymph nodes
Time Frame
1 day
Title
intraoperative lymph node dissection time
Description
(regional analysis:infrapyloric area lymph node,suprapancreatic area lymph node,splenic hilar area lymph node,cardial area lymph node)
Time Frame
1 day
Title
intracavitary anastomosis time
Description
(patients who undergo totally laparoscopic surgery are analyzed)
Time Frame
1 day
Title
intraoperative blood loss
Description
ml
Time Frame
1 day
Title
intraoperative injury
Description
intraoperative injury
Time Frame
1 day
Title
the amount of use of titanium clip
Description
the amount of use of titanium clip
Time Frame
1 day
Title
the rate of conversion to laparotomy
Description
the rate of conversion to laparotomy
Time Frame
1 day
Title
Time to first ambulation
Description
Time to first ambulation
Time Frame
10 days
Title
Time to first flatus
Description
Time to first flatus
Time Frame
10 days
Title
Time to first liquid diet
Description
Time to first liquid diet
Time Frame
10 days
Title
Time to first soft diet
Description
Time to first soft diet
Time Frame
10 days
Title
duration of postoperative hospital stay
Description
duration of postoperative hospital stay
Time Frame
10 days
Title
Complication
Description
(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
Time Frame
30 days;36 months
Title
The daily highest body temperature before discharge
Description
The daily highest body temperature before discharge
Time Frame
7 days
Title
Overall postoperative morbidity and mortality rates
Description
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.
Time Frame
30 days
Title
Hospitalization expenses
Description
dolloars
Time Frame
1 months
Title
3-year disease free survival rate
Description
month
Time Frame
36 months
Title
3-year overall survival rate
Description
month
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changming Huang Huang
Organizational Affiliation
Fujian Medical University Union Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Trials Comparing of HD Versus 4K Laparoscopy for Gastric Cancer
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