Laparoscopy-assisted Pylorus-vagus Nerve Preserving Gastrectomy in the Treatment of Early Gastric Cancer (LAPPG)

November 3, 2019 updated by: RenJi Hospital

Laparoscopy-assisted Pylorus-vagus Nerve Preserving Gastrectomy in the Treatment of Early Gastric Cancer: Clinical Outcomes of a Randomised Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 200127
        • Recruiting
        • Ethics Committee of Renji Hospital, School of Medicine, Shanghai Jiaotong University
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Ethics Committee of Renji Hospital, School of Medicine,Shanghai Jiaotong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pylorus preservation
Patients undergo Laparoscopic Gastrectomy with Pylorus-preservation
Procedure: Pylorus preservation
Patients undergo Laparoscopic Gastrectomy featuring pylorus-preservation
Other Names:
  • Laparoscopic-assisted pylorus preserving gastrectomy
Active Comparator: Distal gastrectomy
Patients undergo Laparoscopic Gastrectomy procedure detailing in distal gastrectomy with D2 lymphadenectomy
Procedure: Distal gastrectomy
Patients undergo laparoscopic gastrectomy in distal gastric resection with D2 lymphadenectomy
Other Names:
  • Laparoscopic-assisted distal gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival
Time Frame: 3 years
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.
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative complications
Time Frame: 30 days
30 days
Postoperative mortality
Time Frame: 30 days
30 days
3 years overall survival
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

November 2, 2019

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

October 7, 2016

First Submitted That Met QC Criteria

October 14, 2016

First Posted (Estimate)

October 18, 2016

Study Record Updates

Last Update Posted (Actual)

November 5, 2019

Last Update Submitted That Met QC Criteria

November 3, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAPPG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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