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

Sponsor
RenJi Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02936193
Collaborator
(none)
100
Enrollment
2
Locations
2
Arms
38
Anticipated Duration (Months)
50
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Pylorus preservation
  • Procedure: Distal gastrectomy
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Laparoscopy-assisted Pylorus-vagus Nerve Preserving Gastrectomy in the Treatment of Early Gastric Cancer: Clinical Outcomes of a Randomised Controlled Trial
Actual Study Start Date :
Aug 1, 2017
Actual Primary Completion Date :
Nov 2, 2019
Anticipated Study Completion Date :
Oct 1, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free Survival [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.

    Secondary Outcome Measures

    1. Postoperative complications [30 days]

    2. Postoperative mortality [30 days]

    3. 3 years overall survival [3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ethics Committee of Renji Hospital, School of Medicine,Shanghai Jiaotong University Shanghai Shanghai China 200127
    2 Ethics Committee of Renji Hospital, School of Medicine, Shanghai Jiaotong University Shanghai China 200127

    Sponsors and Collaborators

    • RenJi Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RenJi Hospital
    ClinicalTrials.gov Identifier:
    NCT02936193
    Other Study ID Numbers:
    • LAPPG
    First Posted:
    Oct 18, 2016
    Last Update Posted:
    Nov 5, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Stomach Neoplasms

    Study Results

    No Results Posted as of Nov 5, 2019