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Comparison Between Double Tract Anastomosis and Esophagogastrostomy After Radical Proximal Gastrectomy

Primary Purpose

Gastric Cancer, GastroEsophageal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Double tract anatomosis
Esophagogastrostomy
Sponsored by
Peking University Cancer Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Double tract, Esophagogastrostomy, Gastric cancer, GastroEsophageal Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients diagnosed as gastric or esophagogastric adenocarcinoma
  2. Age ranges from 18 to 80
  3. Karnofsky assessment no less than 70
  4. Completion of abdominal CT scan and ultrasound endoscopy
  5. Upper gastric cancer (cT1N0M0) or esophagogastric adenocarcinoma (diameter no more than 4 cm)
  6. radical proximal gastrectomy
  7. Normal blood routine examination and biochemical test

Exclusion Criteria:

  1. Patients need to undergo total gastrectomy or distal gastrectomy
  2. Female patients with pregnancy
  3. Not suitable for operation
  4. Patients have already joined other clinical trials

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Double tract anatomosis

    Esophagogastrostomy

    Arm Description

    After the proximal gastrectomy, the purse-string suture is tied at the esophagus stump, and the anvil head is inserted into the esophagus stump using an anvil clamp. A Roux-en-Y esophagojejunostomy (E-stomy) is performed by intracorporeal anastomosis with a circular stapler, and the jejunal stump is closed with a linear stapler. Next, side-to-side gastrojejunostomy (G-stomy), 15 cm below the E-stomy, is performed using 2 linear staplers. Finally, end-to-side jejunojejunostomy (J-stomy), 20 cm below the G-stomy, is performed by 2 linear staplers.

    After the proximal gastrectomy, the purse-string suture is tied at the esophagus stump, and the anvil head is inserted into the esophagus stump using an anvil clamp. Next, end-to-end or side to end esophagogastrostomy is performed with a circular stapler.

    Outcomes

    Primary Outcome Measures

    Rate of reflux esophagitis after operation
    The rate of reflux esophagitis after operation will be assessed by gastrointestinal endoscopy with Los Angeles (LA) classification. the degree of reflux esophagitis will be classified as N, A, B, C or D level, and latter levels represent a more severe reflux esophagitis.

    Secondary Outcome Measures

    postoperative quality of life
    Assessed by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) - C30 questionnaire, the total score ranges from 30 to 126, and higher values represent a worse outcome.
    postoperative quality of life
    Assessed by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) - STO22 questionnaire, the total score ranges from 22 to 88, and higher values represent a worse outcome.

    Full Information

    First Posted
    July 23, 2018
    Last Updated
    November 7, 2018
    Sponsor
    Peking University Cancer Hospital & Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03613142
    Brief Title
    Comparison Between Double Tract Anastomosis and Esophagogastrostomy After Radical Proximal Gastrectomy
    Official Title
    Comparison Between Double Tract Anastomosis and Esophagogastrostomy After Radical Proximal Gastrectomy: A Prospective, Randomized, Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2019 (Anticipated)
    Primary Completion Date
    December 30, 2021 (Anticipated)
    Study Completion Date
    December 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking University Cancer Hospital & Institute

    4. Oversight

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

    5. Study Description

    Brief Summary
    The patients with upper gastric cancer (cT1N0M0) or gastroesophageal adenocarcinoma (diameter less than 4 cm) will be enrolled into this study. Each of these patients will undergo radical proximal gastrectomy and be randomly allocated into one of the two groups, double tract anastomosis group or esophagogastrostomy group. The following data will be collected to compare the difference between the two reconstruction methods: the rate of reflux esophagitis, postoperative quality of life, economic expenditure, the safety of operation, postoperative recovery, postoperative nutrition status and oncological effect. Through the comprehensive analysis, the result of this study will elucidate the best of the reconstruction method after proximal gastrectomy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastric Cancer, GastroEsophageal Cancer
    Keywords
    Double tract, Esophagogastrostomy, Gastric cancer, GastroEsophageal Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    202 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Double tract anatomosis
    Arm Type
    Experimental
    Arm Description
    After the proximal gastrectomy, the purse-string suture is tied at the esophagus stump, and the anvil head is inserted into the esophagus stump using an anvil clamp. A Roux-en-Y esophagojejunostomy (E-stomy) is performed by intracorporeal anastomosis with a circular stapler, and the jejunal stump is closed with a linear stapler. Next, side-to-side gastrojejunostomy (G-stomy), 15 cm below the E-stomy, is performed using 2 linear staplers. Finally, end-to-side jejunojejunostomy (J-stomy), 20 cm below the G-stomy, is performed by 2 linear staplers.
    Arm Title
    Esophagogastrostomy
    Arm Type
    Active Comparator
    Arm Description
    After the proximal gastrectomy, the purse-string suture is tied at the esophagus stump, and the anvil head is inserted into the esophagus stump using an anvil clamp. Next, end-to-end or side to end esophagogastrostomy is performed with a circular stapler.
    Intervention Type
    Procedure
    Intervention Name(s)
    Double tract anatomosis
    Intervention Description
    After the proximal gastrectomy, the purse-string suture is tied at the esophagus stump, and the anvil head is inserted into the esophagus stump using an anvil clamp. A Roux-en-Y esophagojejunostomy (E-stomy) is performed by intracorporeal anastomosis with a circular stapler, and the jejunal stump is closed with a linear stapler. Next, side-to-side gastrojejunostomy (G-stomy), 15 cm below the E-stomy, is performed using 2 linear staplers. Finally, end-to-side jejunojejunostomy (J-stomy), 20 cm below the G-stomy, is performed by 2 linear staplers.
    Intervention Type
    Procedure
    Intervention Name(s)
    Esophagogastrostomy
    Intervention Description
    After the proximal gastrectomy, the purse-string suture is tied at the esophagus stump, and the anvil head is inserted into the esophagus stump using an anvil clamp. Next, end-to-end or side to end esophagogastrostomy is performed with a circular stapler.
    Primary Outcome Measure Information:
    Title
    Rate of reflux esophagitis after operation
    Description
    The rate of reflux esophagitis after operation will be assessed by gastrointestinal endoscopy with Los Angeles (LA) classification. the degree of reflux esophagitis will be classified as N, A, B, C or D level, and latter levels represent a more severe reflux esophagitis.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    postoperative quality of life
    Description
    Assessed by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) - C30 questionnaire, the total score ranges from 30 to 126, and higher values represent a worse outcome.
    Time Frame
    12months
    Title
    postoperative quality of life
    Description
    Assessed by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) - STO22 questionnaire, the total score ranges from 22 to 88, and higher values represent a worse outcome.
    Time Frame
    12months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients diagnosed as gastric or esophagogastric adenocarcinoma Age ranges from 18 to 80 Karnofsky assessment no less than 70 Completion of abdominal CT scan and ultrasound endoscopy Upper gastric cancer (cT1N0M0) or esophagogastric adenocarcinoma (diameter no more than 4 cm) radical proximal gastrectomy Normal blood routine examination and biochemical test Exclusion Criteria: Patients need to undergo total gastrectomy or distal gastrectomy Female patients with pregnancy Not suitable for operation Patients have already joined other clinical trials
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xin Ji, M.D.
    Phone
    +86 18601201053
    Email
    18601201053@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xin Ji, M.D.
    Organizational Affiliation
    Peking University Cancer Hospital & Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Comparison Between Double Tract Anastomosis and Esophagogastrostomy After Radical Proximal Gastrectomy

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