Back to resultsLaparoscopy-assisted Pylorus-vagus Nerve Preserving Gastrectomy in the Treatment of Early Gastric Cancer (LAPPG)
Primary Purpose
Early Gastric Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pylorus preservation
Distal gastrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Early Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- Age older than 18 and younger than 75 years
- Primary gastric adenocarcinoma confirmed pathologically by endoscopic biopsy
- cT1-2N0-3M0 at preoperative evaluation according to AJCC Cancer Staging Manual, 7th Edition
- Expected curative resection via distal subtotal gastrectomy with D2 lymphadenectomy
- Written informed consent
Exclusion Criteria:
- Pregnant or breast-feeding women
- Severe mental disorder
- Previous upper abdominal surgery (except laparoscopic cholecystectomy)
- Previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection
- Other malignant disease within the past 5 years
- Previous neoadjuvant chemotherapy or radiotherapy
- Unstable angina, myocardial infarction, or cerebrovascular accident within the past 6 months
- Continuous systematic administration of corticosteroids within 1 month before the study
- Requirement of simultaneous surgery for other diseases
- Emergency surgery due to a complication (bleeding, obstruction, or perforation) caused by gastric cancer
Sites / Locations
- Ethics Committee of Renji Hospital, School of Medicine,Shanghai Jiaotong UniversityRecruiting
- Ethics Committee of Renji Hospital, School of Medicine, Shanghai Jiaotong UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pylorus preservation
Distal gastrectomy
Arm Description
Patients undergo Laparoscopic Gastrectomy with Pylorus-preservation
Patients undergo Laparoscopic Gastrectomy procedure detailing in distal gastrectomy with D2 lymphadenectomy
Outcomes
Primary Outcome Measures
Progression-free Survival
It is the time that passes from the first date after treatment and the date on which gastric cancer progresses, as demonstrated by laboratory testing, radiologic testing, or clinically.
Secondary Outcome Measures
Postoperative complications
Postoperative mortality
3 years overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02936193
Brief Title
Laparoscopy-assisted Pylorus-vagus Nerve Preserving Gastrectomy in the Treatment of Early Gastric Cancer
Acronym
LAPPG
Official Title
Laparoscopy-assisted Pylorus-vagus Nerve Preserving Gastrectomy in the Treatment of Early Gastric Cancer: Clinical Outcomes of a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
November 2, 2019 (Actual)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The safety and efficacy of Laparoscopy-assisted Pylorus-preserving Gastrectomy (LAPPG) for the treatment of early gastric cancer (EGC) remain controversial. The investigators conducted a randomized controlled trial to compare LAPPG and laparoscopic distal gastrectomy with D2 lymph node dissections for EGC.
Detailed Description
During the procedure, the distal part of the stomach is resected, but a pyloric cuff 2-3 cm wide is preserved. The right gastric artery and the infrapyloric artery are preserved to maintain the blood supply to the pyloric cuff. In addition, the hepatic and pyloric branches of the vagal nerves are preserved to maintain pyloric function. The celiac branch of the posterior vagal trunk is sometimes preserved. All regional nodes except the suprapyloric nodes (No. 5) should be dissected as in the standard D2 procedure. However, there are technical challenges associated with completing all of these procedures.The five-year survival rate after PPG with modified D2 lymph node dissection ranges from 95% to 98%. This rate is comparable to the five-year survival rate after gastric resection for EGC, which ranges from 90% to 98%. In terms of oncologic safety, PPG seems reasonably safe for EGC when the accuracy of preoperative diagnosis can be assured
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pylorus preservation
Arm Type
Experimental
Arm Description
Patients undergo Laparoscopic Gastrectomy with Pylorus-preservation
Arm Title
Distal gastrectomy
Arm Type
Active Comparator
Arm Description
Patients undergo Laparoscopic Gastrectomy procedure detailing in distal gastrectomy with D2 lymphadenectomy
Intervention Type
Procedure
Intervention Name(s)
Pylorus preservation
Other Intervention Name(s)
Laparoscopic-assisted pylorus preserving gastrectomy
Intervention Description
Patients undergo Laparoscopic Gastrectomy featuring pylorus-preservation
Intervention Type
Procedure
Intervention Name(s)
Distal gastrectomy
Other Intervention Name(s)
Laparoscopic-assisted distal gastrectomy
Intervention Description
Patients undergo laparoscopic gastrectomy in distal gastric resection with D2 lymphadenectomy
Primary Outcome Measure Information:
Title
Progression-free Survival
Description
It is the time that passes from the first date after treatment and the date on which gastric cancer progresses, as demonstrated by laboratory testing, radiologic testing, or clinically.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Postoperative complications
Time Frame
30 days
Title
Postoperative mortality
Time Frame
30 days
Title
3 years overall survival
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age older than 18 and younger than 75 years
Primary gastric adenocarcinoma confirmed pathologically by endoscopic biopsy
cT1-2N0-3M0 at preoperative evaluation according to AJCC Cancer Staging Manual, 7th Edition
Expected curative resection via distal subtotal gastrectomy with D2 lymphadenectomy
Written informed consent
Exclusion Criteria:
Pregnant or breast-feeding women
Severe mental disorder
Previous upper abdominal surgery (except laparoscopic cholecystectomy)
Previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection
Other malignant disease within the past 5 years
Previous neoadjuvant chemotherapy or radiotherapy
Unstable angina, myocardial infarction, or cerebrovascular accident within the past 6 months
Continuous systematic administration of corticosteroids within 1 month before the study
Requirement of simultaneous surgery for other diseases
Emergency surgery due to a complication (bleeding, obstruction, or perforation) caused by gastric cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Tu, MD
Phone
008618616547270
Email
tl19870228@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gang Zhao, PhD
Phone
0086-021-68383731
Email
zhaogang74313@aliyun.com
Facility Information:
Facility Name
Ethics Committee of Renji Hospital, School of Medicine,Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qi Lu
Phone
0086-021-68383364
Email
rjluqi@hotmail.com
Facility Name
Ethics Committee of Renji Hospital, School of Medicine, Shanghai Jiaotong University
City
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Cao, PhD
Phone
0086-021-686383751
Email
caohuishcn@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Laparoscopy-assisted Pylorus-vagus Nerve Preserving Gastrectomy in the Treatment of Early Gastric Cancer
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