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出境医 / 临床实验 / Trials Comparing of HD Versus 4K Laparoscopy for Gastric Cancer

Trials Comparing of HD Versus 4K Laparoscopy for Gastric Cancer

Study Description
Brief Summary:
The purpose of this study is to explore the feasibility of 4K Laparoscopic Surgery for Gastric Cancer.

Condition or disease Intervention/treatment Phase
Stomach Neoplasms Procedure: 4K Laparoscopic Surgery Procedure: HD Laparoscopic Surgery Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 502 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trials Comparing Clinical Outcome of HD Versus 4K Laparoscopy for Gastric Cancer(FUGES-017)
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : July 15, 2020
Estimated Study Completion Date : July 15, 2023
Arms and Interventions
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.
Outcome Measures
Primary Outcome Measures :
  1. operating time [ Time Frame: 1 day ]
    day


Secondary Outcome Measures :
  1. The number of lymph node dissection [ Time Frame: 1 day ]
    number

  2. the number of positive lymph nodes [ Time Frame: 1 day ]
    the number of positive lymph nodes

  3. intraoperative lymph node dissection time [ Time Frame: 1 day ]
    (regional analysis:infrapyloric area lymph node,suprapancreatic area lymph node,splenic hilar area lymph node,cardial area lymph node)

  4. intracavitary anastomosis time [ Time Frame: 1 day ]
    (patients who undergo totally laparoscopic surgery are analyzed)

  5. intraoperative blood loss [ Time Frame: 1 day ]
    ml

  6. intraoperative injury [ Time Frame: 1 day ]
    intraoperative injury

  7. the amount of use of titanium clip [ Time Frame: 1 day ]
    the amount of use of titanium clip

  8. the rate of conversion to laparotomy [ Time Frame: 1 day ]
    the rate of conversion to laparotomy

  9. Time to first ambulation [ Time Frame: 10 days ]
    Time to first ambulation

  10. Time to first flatus [ Time Frame: 10 days ]
    Time to first flatus

  11. Time to first liquid diet [ Time Frame: 10 days ]
    Time to first liquid diet

  12. Time to first soft diet [ Time Frame: 10 days ]
    Time to first soft diet

  13. duration of postoperative hospital stay [ Time Frame: 10 days ]
    duration of postoperative hospital stay

  14. Complication [ Time Frame: 30 days;36 months ]
    (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

  15. The daily highest body temperature before discharge [ Time Frame: 7 days ]
    The daily highest body temperature before discharge

  16. Overall postoperative morbidity and mortality rates [ Time Frame: 30 days ]

    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.


  17. Hospitalization expenses [ Time Frame: 1 months ]
    dolloars

  18. 3-year disease free survival rate [ Time Frame: 36 months ]
    month

  19. 3-year overall survival rate [ Time Frame: 36 months ]
    month


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   19 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
Layout table for location information
China, Fujian
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350000
Sponsors and Collaborators
Fujian Medical University
Investigators
Layout table for investigator information
Study Chair: Changming Huang Huang Fujian Medical University Union Hospital
Tracking Information
First Submitted Date  ICMJE May 9, 2019
First Posted Date  ICMJE July 8, 2019
Last Update Posted Date January 7, 2020
Actual Study Start Date  ICMJE July 15, 2019
Estimated Primary Completion Date July 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2019) 		operating time [ Time Frame: 1 day ]
day
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2019)
  • The number of lymph node dissection [ Time Frame: 1 day ]
    number
  • the number of positive lymph nodes [ Time Frame: 1 day ]
    the number of positive lymph nodes
  • intraoperative lymph node dissection time [ Time Frame: 1 day ]
    (regional analysis:infrapyloric area lymph node,suprapancreatic area lymph node,splenic hilar area lymph node,cardial area lymph node)
  • intracavitary anastomosis time [ Time Frame: 1 day ]
    (patients who undergo totally laparoscopic surgery are analyzed)
  • intraoperative blood loss [ Time Frame: 1 day ]
    ml
  • intraoperative injury [ Time Frame: 1 day ]
    intraoperative injury
  • the amount of use of titanium clip [ Time Frame: 1 day ]
    the amount of use of titanium clip
  • the rate of conversion to laparotomy [ Time Frame: 1 day ]
    the rate of conversion to laparotomy
  • Time to first ambulation [ Time Frame: 10 days ]
    Time to first ambulation
  • Time to first flatus [ Time Frame: 10 days ]
    Time to first flatus
  • Time to first liquid diet [ Time Frame: 10 days ]
    Time to first liquid diet
  • Time to first soft diet [ Time Frame: 10 days ]
    Time to first soft diet
  • duration of postoperative hospital stay [ Time Frame: 10 days ]
    duration of postoperative hospital stay
  • Complication [ Time Frame: 30 days;36 months ]
    (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 [ Time Frame: 7 days ]
    The daily highest body temperature before discharge
  • Overall postoperative morbidity and mortality rates [ Time Frame: 30 days ]
    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 [ Time Frame: 1 months ]
    dolloars
  • 3-year disease free survival rate [ Time Frame: 36 months ]
    month
  • 3-year overall survival rate [ Time Frame: 36 months ]
    month
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trials Comparing of HD Versus 4K Laparoscopy for Gastric Cancer
Official Title  ICMJE Randomized Controlled Trials Comparing Clinical Outcome of HD Versus 4K Laparoscopy for Gastric Cancer(FUGES-017)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stomach Neoplasms
Intervention  ICMJE
  • Procedure: 4K Laparoscopic Surgery
    4K 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.
Study Arms  ICMJE
  • Experimental: 4K Laparoscopic Surgery
    4K Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.
    Intervention: Procedure: 4K Laparoscopic Surgery
  • Active Comparator: HD Laparoscopic Surgery
    HD Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.
    Intervention: Procedure: HD Laparoscopic Surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: July 2, 2019) 		502
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 15, 2023
Estimated Primary Completion Date July 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04010006
Other Study ID Numbers  ICMJE FUGES-017
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chang-Ming Huang, Prof., Fujian Medical University
Study Sponsor  ICMJE Fujian Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Changming Huang Huang Fujian Medical University Union Hospital
PRS Account Fujian Medical University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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