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

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: Gastric Cancer
• Intervention / Treatment: Procedure: Laparoscopy-assisted 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

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

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

Collaborators and Investigators

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

Study record dates

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: laparoscopy; gastric cancer; reflux esophagitis; total gastrectomy; proximal gastrectomy; double tract reconstruction
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: SNUBHGS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO