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