Laparoscopy-assisted Proximal Gastrectomy Versus and Laparoscopy-assisted Total Gastrectomy (PRAPT)

January 6, 2017 updated by: Hyung-Ho Kim, Seoul National University Bundang Hospital

Phase III Prospective Randomized Clinical Trial of Laparoscopy-assisted Proximal Gastrectomy (LAPG) and Laparoscopy-assisted Total Gastrectomy (LATG) for Upper Gastric Cancer. (Multicenter Study)

The choice of surgical strategy for patients with proximal gastric cancer is controversial mainly because proximal gastrectomy is infamous for high rates of reflux symptoms and anastomotic stricture. but there are no prospective randomized trials until now.

The primary end point of this study is whether the rate of reflux esophagitis is different or not between LAPG and LATG. Through this study, we

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Prospective Randomized Clinical Trials between Laparoscopy-assisted Proximal Gastrectomy and Laparoscopy-assisted Total Gastrectomy.

LAPG reconstruction: double tract reconstruction (3 anastomosis, intracorporeal Roux-en Y esophago-jejunostomy, extracorporeal gastro-jejunostomy 10cm below esophago-jejunostomy,extracorporeal jejuno-jejunostomy 20cm below gastro-jejunostomy)

LATG reconstruction: intracorporeal Roux-en Y esophago-jejunostomy

Primary end point : incidence of reflux esophagitis after operation

Sample Size : LAPG 97 cases, LATG 97 cases (p1=0.018 p2=0.018, a=0.05, b=0.80) Non-inferiority test, non-inferior margin (delta) : 0.05. Sample size calculated by our MRCC(Medical Research Collaborating Center, http://mrcc.snubh.org)

Study duration : 48 months (enrollment 36months, follow-up 12months)

Reflux esophagitis evaluation methods

  1. Ambulatory 24hr-pH esophageal holter monitoring for acid reflux
  2. DISIDA scan for bile reflux
  3. Endoscopic evaluation (Grading according to LA classification)
  4. Visick score (subjective symptoms)
  5. EORTC sto 22 and GIQLI evaluation (Quality of Life)
  6. Nutritional Benefits (Body weight, Triceps Skin folds Thickness, Blood test)
  7. Upper gastrointestinal study
  8. Gastric emptying scan

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • Korea, Republic of
    • Gyenggi
      • Seongnam, Gyenggi, Korea, Republic of
        • Seoul National University Bundang Hospital

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

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 20~80
  • Informed consent
  • No other malignancies

  • Proximal gastric cancer met by following conditions

    1. Lesion located on proximal stomach (upper one third)
    2. Lesion below 5cm in size
    3. Lesion confined to proper muscle depth (cT2)
    4. No evidence of metastatic enlarged LN on #5, 6, 4d, 10 basins and other distant metastasis. (cN1)

Exclusion Criteria:

  • If patients is only suitable to total gastrectomy, he will be excluded.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: LAPG
LAPG : laparoscopy-assisted proximal gastrectomy with double tract reconstruction group
Procedure: Laparoscopy-assisted gastrectomy
Laparoscopy-assisted proximal gastrectomy versus Laparoscopy-assisted total gastrectomy
ACTIVE_COMPARATOR: LATG
LATG : laparoscopy-assisted total gastrectomy group
Procedure: Laparoscopy-assisted gastrectomy
Laparoscopy-assisted proximal gastrectomy versus Laparoscopy-assisted total gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of reflux esophagitis
Time Frame: postoperative 3 month
Comprehesive evaulation by 24hr pH monitoring, DISIDA scan, Endoscopic evaluation according to LA classification and Visick score
postoperative 3 month
Rate of reflux esophagitis
Time Frame: postoperative 6 month
Comprehesive evaulation by 24hr pH monitoring, DISIDA scan, Endoscopic evaluation according to LA classification and Visick score
postoperative 6 month
Rate of reflux esophagitis
Time Frame: postoperative 12 month
Comprehesive evaulation by 24hr pH monitoring, DISIDA scan, Endoscopic evaluation according to LA classification and Visick score
postoperative 12 month

Collaborators and Investigators

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

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Hyung-Ho Kim, M.D., Ph.D., Seoul National University Bundang 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

July 1, 2012

Primary Completion (ACTUAL)

November 1, 2012

Study Completion (ACTUAL)

November 1, 2012

Study Registration Dates

First Submitted

September 10, 2011

First Submitted That Met QC Criteria

September 13, 2011

First Posted (ESTIMATE)

September 14, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 9, 2017

Last Update Submitted That Met QC Criteria

January 6, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBHGS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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