NCT02936193

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

November 5, 2019

Status Verified

April 1, 2019

Enrollment Period

2.3 years

First QC Date

October 7, 2016

Last Update Submit

November 3, 2019

Conditions

Early Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 years

Secondary Outcomes (3)

  • Postoperative complications

    30 days

  • Postoperative mortality

    30 days

  • 3 years overall survival

    3 years

Study Arms (2)

Pylorus preservation

EXPERIMENTAL

Patients undergo Laparoscopic Gastrectomy with Pylorus-preservation

Procedure: Pylorus preservation

Distal gastrectomy

ACTIVE COMPARATOR

Patients undergo Laparoscopic Gastrectomy procedure detailing in distal gastrectomy with D2 lymphadenectomy

Procedure: Distal gastrectomy

Interventions

Pylorus preservationPROCEDURE

Patients undergo Laparoscopic Gastrectomy featuring pylorus-preservation

Also known as: Laparoscopic-assisted pylorus preserving gastrectomy
Pylorus preservation
Distal gastrectomyPROCEDURE

Patients undergo laparoscopic gastrectomy in distal gastric resection with D2 lymphadenectomy

Also known as: Laparoscopic-assisted distal gastrectomy
Distal gastrectomy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ethics Committee of Renji Hospital, School of Medicine,Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Ethics Committee of Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, 200127, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Gastroenterostomy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Anastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Central Study Contacts

Lin Tu, MD

CONTACT

008618616547270tl19870228@hotmail.com

Gang Zhao, PhD

CONTACT

0086-021-68383731zhaogang74313@aliyun.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2016

First Posted

October 18, 2016

Study Start

August 1, 2017

Primary Completion

November 2, 2019

Study Completion

October 1, 2020

Last Updated

November 5, 2019

Record last verified: 2019-04

Locations

CN(2)