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The Advantages and Disadvantages Between Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction After Laparoscopy-assisted Distal Gastrectomy for Gastric

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Uncut Roux-en-Y Reconstruction
Billroth II Reconstruction
Sponsored by
Jilin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring reflux, residue, Gastric stasis, Emptying time

Eligibility Criteria

undefined - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of distal gastric cancer
  • underwent laparoscopy-assisted distal gastrectomy

Exclusion Criteria:

  • have simultaneously other cancer
  • have severe systemic inflammatory disease ,serious illness such as diabetes, chronic lung diseases
  • have upper gastrointestinal surgery
  • can't bear the gastric tube
  • the period is too late or the tumor is too large to carry on a laparoscopy assisted radical distal gastrectomy

Sites / Locations

  • the first hospital of Jilin UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Uncut Roux-en-Y Reconstruction

Billroth II Reconstruction

Arm Description

Uncut Roux-en-Y Reconstruction will be used after laparoscopy-assisted distal gastrectomy for early gastric cancer.

Billroth II Reconstruction will be used after laparoscopy-assisted distal gastrectomy for early gastric cancer.

Outcomes

Primary Outcome Measures

The time of reconstruction during operations of Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction
The time of reconstruction operation will be recorded in the operating note by nurses in minutes.
change of potential of hydrogen ( pH) in remnant stomach
In the morning of 1-6 days after operation , monitor the number of gastric juice's potential of hydrogen ( pH) value through gastric tube and write down the data. So if the data is greater than 7,the complication of bile reflux happened
the amount of blood loss during operations of Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction
During the operation the amount of blood loss will be recorded in the operating note by nurses in milliliters.

Secondary Outcome Measures

the number of patients with the complication of Residual food
During the upper gastrointestinal radiography,if there is residual food,the meglumine diatrizoate will be separate and then write down the number.
the number of patients with the complication of Reflux esophagitis
During the upper gastrointestinal radiography,if there is meglumine diatrizoate refluxing to esophagus,it will be observed and written down in number.

Full Information

First Posted
January 29, 2016
Last Updated
December 29, 2016
Sponsor
Jilin University
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1. Study Identification

Unique Protocol Identification Number
NCT02694081
Brief Title
The Advantages and Disadvantages Between Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction After Laparoscopy-assisted Distal Gastrectomy for Gastric
Official Title
The Advantages and Disadvantages Between Uncut Roux-en-Y Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
February 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jilin University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The Advantages and Disadvantages Between Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction After Laparoscopy-assisted Distal Gastrectomy for Gastric.
Detailed Description
To search which is the better reconstructions by comparing and analyzing the advantages and disadvantages between Uncut Roux-en-Y and Billroth II reconstructions after laparoscopy-assisted distal gastrectomy for gastric cancer. Method: It's a prospective study including all patients underwent laparoscopy-assisted distal gastrectomy (LADG) in the First Hospital of Jilin University, from February 2016 to February 2017. All surgical procedures will be performed by the single surgery team, which is leaded by professor Wang Quan. The reconstruction method will be selected randomly from Uncut Roux-en-Y and Billroth II anastomosis by drawing lots preoperatively without distinct indications. Clinical data, operation data and perioperative complications and related physiological indexes of differences.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
reflux, residue, Gastric stasis, Emptying time

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Uncut Roux-en-Y Reconstruction
Arm Type
Experimental
Arm Description
Uncut Roux-en-Y Reconstruction will be used after laparoscopy-assisted distal gastrectomy for early gastric cancer.
Arm Title
Billroth II Reconstruction
Arm Type
Active Comparator
Arm Description
Billroth II Reconstruction will be used after laparoscopy-assisted distal gastrectomy for early gastric cancer.
Intervention Type
Procedure
Intervention Name(s)
Uncut Roux-en-Y Reconstruction
Intervention Description
All surgical procedures will be performed by the single surgery team ,which is leaded by professor Wang Quan. Uncut Roux-en-Y construction will be used in this group.
Intervention Type
Procedure
Intervention Name(s)
Billroth II Reconstruction
Intervention Description
All surgical procedures will be performed by the single surgery team ,which is leaded by professor Wang Quan. Uncut Roux-en-Y construction will be used in this group.
Primary Outcome Measure Information:
Title
The time of reconstruction during operations of Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction
Description
The time of reconstruction operation will be recorded in the operating note by nurses in minutes.
Time Frame
within 2 hours after surgery
Title
change of potential of hydrogen ( pH) in remnant stomach
Description
In the morning of 1-6 days after operation , monitor the number of gastric juice's potential of hydrogen ( pH) value through gastric tube and write down the data. So if the data is greater than 7,the complication of bile reflux happened
Time Frame
1-6 days after surgery
Title
the amount of blood loss during operations of Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction
Description
During the operation the amount of blood loss will be recorded in the operating note by nurses in milliliters.
Time Frame
within 2 hours after surgery
Secondary Outcome Measure Information:
Title
the number of patients with the complication of Residual food
Description
During the upper gastrointestinal radiography,if there is residual food,the meglumine diatrizoate will be separate and then write down the number.
Time Frame
6 month after surgery
Title
the number of patients with the complication of Reflux esophagitis
Description
During the upper gastrointestinal radiography,if there is meglumine diatrizoate refluxing to esophagus,it will be observed and written down in number.
Time Frame
6 month after surgery
Other Pre-specified Outcome Measures:
Title
the number of patients with the complication of gastroesophageal reflux disease(GERD)
Description
all patients of this clinical trial will be investigated by Gastroesophageal reflux disease questionnaire(GerdQ),and all patients whose score is beyond 8 will be collected.
Time Frame
6 month after surgery

10. Eligibility

Sex
All
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of distal gastric cancer underwent laparoscopy-assisted distal gastrectomy Exclusion Criteria: have simultaneously other cancer have severe systemic inflammatory disease ,serious illness such as diabetes, chronic lung diseases have upper gastrointestinal surgery can't bear the gastric tube the period is too late or the tumor is too large to carry on a laparoscopy assisted radical distal gastrectomy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong Yang, postgraduate
Phone
18243052038
Email
714488468@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quan Wang, professor
Organizational Affiliation
The First Hospital of Jilin University
Official's Role
Study Director
Facility Information:
Facility Name
the first hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Yang, master
Email
714488468@qq.com
First Name & Middle Initial & Last Name & Degree
Quan Wang, proffessor
Email
18844097668@163.com

12. IPD Sharing Statement

Learn more about this trial

The Advantages and Disadvantages Between Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction After Laparoscopy-assisted Distal Gastrectomy for Gastric

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