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The Safety of Totally Laparoscopic Versus Laparoscopy-Assisted Total Gastrectomy.

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Totally Laparoscopic Total Gastrectomy
Laparoscopy-Assisted Total Gastrectomy
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Aged 18-75 years；
  2. Primary lesion is diagnosed with endometrial biopsy as adenocarcinoma of the stomach or esophagogastric junction, including: papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), mixed adenocarcinoma, etc.；
  3. Clinical stage cT1N0M0, cT1N1M0, cT2N0M0；
  4. The gastric primary lesion is located in the body or fundus of stomach or the esophagogastric junction. It is expected that total gastrectomy with D1+/D2 lymph node dissection achieves R0 resection (multiple primary cancers are also applicable)；
  5. BMI(Body Mass Index)<30 kg/m2；
  6. No history of upper abdominal surgery (except for laparoscopic cholecystectomy)；
  7. No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.；
  8. Preoperative ECOG (Eastern Cooperative Oncology Group) performance status score 0 or 1；
  9. Preoperative ASA (American Society of Anesthesiologists) scoring I-III；
  10. Sufficient vital organ functions；
  11. Signed informed consent.

Exclusion Criteria:

  1. Preoperative examination indicates disease stage cStage II or above；
  2. Women during pregnancy or lactation；
  3. Suffer from other malignant tumors within 5 years；
  4. Preoperative body temperature ≥ 38°C or complicated with infectious diseases requiring systemic treatment；
  5. Severe mental illness；
  6. Severe respiratory disease；
  7. Severe liver and kidney dysfunction；
  8. History of unstable angina or myocardial infarction within 6 months；
  9. History of cerebral infarction or cerebral hemorrhage within 6 months；
  10. Continuous application of glucocorticoid within 1 month (except for topical application)；
  11. Accompanied by gastric cancer complications (bleeding, perforation, obstruction, etc.) ；
  12. The patient has participated in or is participating in other clinical studies (within 6 months).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Totally Laparoscopic Total Gastrectomy

    Laparoscopy-Assisted Total Gastrectomy

    Arm Description

    Totally laparoscopic total gastrectomy will be performed for the treatment of patients assigned to this group.

    Laparoscopy-assisted total gastrectomy will be performed for the treatment of patients assigned to this group.

    Outcomes

    Primary Outcome Measures

    The incidence of postoperative morbidity
    Refers to the incidence of early postoperative complications. The early postoperative complications are defined as the events observed within postoperative 30 days.

    Secondary Outcome Measures

    Quality of life score
    Quality of life scores of the patients are evaluated based on EORTC C30 questionnaire at the 3rd, 6th and 12th months after operation.
    Quality of life score
    Quality of life scores of the patients are evaluated based on STO22 questionnaire at the 3rd, 6th and 12th months after operation.
    Overall incidence of postoperative morbidity
    Refers to the incidence of overall postoperative complications observed during follow-up period.

    Full Information

    First Posted
    April 13, 2020
    Last Updated
    April 16, 2020
    Sponsor
    The First Affiliated Hospital with Nanjing Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04351321
    Brief Title
    The Safety of Totally Laparoscopic Versus Laparoscopy-Assisted Total Gastrectomy.
    Official Title
    A Multicenter, Randomized, Controlled Clinical Trial of the Safety of Totally Laparoscopic Versus Laparoscopy-Assisted Total Gastrectomy for Gastric Cancer.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2020 (Anticipated)
    Primary Completion Date
    August 2022 (Anticipated)
    Study Completion Date
    August 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The First Affiliated Hospital with Nanjing Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To compare the short-term surgical safety and postoperative quality of life of totally laparoscopic versus laparoscopy-assisted total gastrectomy and to evaluate the superiority of totally laparoscopic total gastrectomy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastric Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    560 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Totally Laparoscopic Total Gastrectomy
    Arm Type
    Experimental
    Arm Description
    Totally laparoscopic total gastrectomy will be performed for the treatment of patients assigned to this group.
    Arm Title
    Laparoscopy-Assisted Total Gastrectomy
    Arm Type
    Active Comparator
    Arm Description
    Laparoscopy-assisted total gastrectomy will be performed for the treatment of patients assigned to this group.
    Intervention Type
    Procedure
    Intervention Name(s)
    Totally Laparoscopic Total Gastrectomy
    Intervention Description
    Totally laparoscopic total gastrectomy will be performed in patients with gastric or esophagogastric junction adenocarcinoma of preoperative clinical stage I (T1N0M0, T1N1M0, T2N0M0) with D1+/D2 lymph node dissection.
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopy-Assisted Total Gastrectomy
    Intervention Description
    Laparoscopy-Assisted Total Gastrectomy will be performed in patients with gastric or esophagogastric junction adenocarcinoma of preoperative clinical stage I (T1N0M0, T1N1M0, T2N0M0) with D1+/D2 lymph node dissection.
    Primary Outcome Measure Information:
    Title
    The incidence of postoperative morbidity
    Description
    Refers to the incidence of early postoperative complications. The early postoperative complications are defined as the events observed within postoperative 30 days.
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    Quality of life score
    Description
    Quality of life scores of the patients are evaluated based on EORTC C30 questionnaire at the 3rd, 6th and 12th months after operation.
    Time Frame
    3, 6 and 12 months
    Title
    Quality of life score
    Description
    Quality of life scores of the patients are evaluated based on STO22 questionnaire at the 3rd, 6th and 12th months after operation.
    Time Frame
    3, 6 and 12 months
    Title
    Overall incidence of postoperative morbidity
    Description
    Refers to the incidence of overall postoperative complications observed during follow-up period.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged 18-75 years； Primary lesion is diagnosed with endometrial biopsy as adenocarcinoma of the stomach or esophagogastric junction, including: papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), mixed adenocarcinoma, etc.； Clinical stage cT1N0M0, cT1N1M0, cT2N0M0； The gastric primary lesion is located in the body or fundus of stomach or the esophagogastric junction. It is expected that total gastrectomy with D1+/D2 lymph node dissection achieves R0 resection (multiple primary cancers are also applicable)； BMI(Body Mass Index)<30 kg/m2； No history of upper abdominal surgery (except for laparoscopic cholecystectomy)； No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.； Preoperative ECOG (Eastern Cooperative Oncology Group) performance status score 0 or 1； Preoperative ASA (American Society of Anesthesiologists) scoring I-III； Sufficient vital organ functions； Signed informed consent. Exclusion Criteria: Preoperative examination indicates disease stage cStage II or above； Women during pregnancy or lactation； Suffer from other malignant tumors within 5 years； Preoperative body temperature ≥ 38°C or complicated with infectious diseases requiring systemic treatment； Severe mental illness； Severe respiratory disease； Severe liver and kidney dysfunction； History of unstable angina or myocardial infarction within 6 months； History of cerebral infarction or cerebral hemorrhage within 6 months； Continuous application of glucocorticoid within 1 month (except for topical application)； Accompanied by gastric cancer complications (bleeding, perforation, obstruction, etc.) ； The patient has participated in or is participating in other clinical studies (within 6 months).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zekuan Xu, M.D., Ph.D.
    Phone
    +86-025-68306844
    Email
    xuzekuan@njmu.edu.cn

    12. IPD Sharing Statement

    Learn more about this trial

    The Safety of Totally Laparoscopic Versus Laparoscopy-Assisted Total Gastrectomy.

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