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Trials Comparing of HD Versus 4K Laparoscopy for Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010006
Recruitment Status : Enrolling by invitation
First Posted : July 8, 2019
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
Chang-Ming Huang, Prof., Fujian Medical University

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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.




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010006


Locations
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China, Fujian
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350000
Sponsors and Collaborators
Fujian Medical University
Investigators
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Study Chair: Changming Huang Huang Fujian Medical University Union Hospital
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Responsible Party: Chang-Ming Huang, Prof., Director, Head of gastric surgery, Principal Investigator, Clinical Professor, Fujian Medical University
ClinicalTrials.gov Identifier: NCT04010006    
Other Study ID Numbers: FUGES-017
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chang-Ming Huang, Prof., Fujian Medical University:
Stomach Neoplasms
Laparoscopy
Additional relevant MeSH terms:
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Stomach Neoplasms
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases