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

This study is currently recruiting participants.
Verified July 2012 by Seoul National University Bundang Hospital
Sponsor:
Information provided by (Responsible Party):
Hyung-Ho Kim, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01433861
First received: September 10, 2011
Last updated: July 15, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Gastric Cancer
 Procedure: Laparoscopy-assisted gastrectomy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Prospective Randomized Clinical Trial of Laparoscopy-assisted Proximal Gastrectomy (LAPG) and Laparoscopy-assisted Total Gastrectomy (LATG) for Upper Gastric Cancer. (Multicenter Study)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Rate of reflux esophagitis [ Time Frame: postoperative 3 month ] [ Designated as safety issue: Yes ]
    Comprehesive evaulation by 24hr pH monitoring, DISIDA scan, Endoscopic evaluation according to LA classification and Visick score

  • Rate of reflux esophagitis [ Time Frame: postoperative 6 month ] [ Designated as safety issue: Yes ]
    Comprehesive evaulation by 24hr pH monitoring, DISIDA scan, Endoscopic evaluation according to LA classification and Visick score

  • Rate of reflux esophagitis [ Time Frame: postoperative 12 month ] [ Designated as safety issue: Yes ]
    Comprehesive evaulation by 24hr pH monitoring, DISIDA scan, Endoscopic evaluation according to LA classification and Visick score


Estimated Enrollment: 194
Study Start Date: July 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01433861

Contacts
Contact: Hyung-Ho Kim, M.D., Ph.D. +82-10-3079-7095 hhkim@snubh.org
Contact: Sang-Hoon Ahn, M.D. +82-10-3667-1803 viscaria@snubh.org

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyenggi, Korea, Republic of
Contact: Hyung-Ho Kim, M.D., Ph.D.     +82-10-3079-7095     hhkim@snubh.org    
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Hyung-Ho Kim, M.D., Ph.D. Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Hyung-Ho Kim, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01433861     History of Changes
Other Study ID Numbers: SNUBHGS
Study First Received: September 10, 2011
Last Updated: July 15, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Bundang Hospital:
gastric cancer
proximal gastrectomy
total gastrectomy
 laparoscopy
reflux esophagitis
double tract reconstruction

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on May 23, 2013