Laparoscopy-assisted Proximal Gastrectomy Versus and Laparoscopy-assisted Total Gastrectomy

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01433861

Acronym

PRAPT

Enrollment

Registered

2011-09-14

Start date

2012-07-31

Completion date

2012-11-30

Last updated

2017-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

gastric cancer, proximal gastrectomy, total gastrectomy, laparoscopy, reflux esophagitis, double tract reconstruction

Brief summary

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

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

Interventions

PROCEDURELaparoscopy-assisted gastrectomy

Laparoscopy-assisted proximal gastrectomy versus Laparoscopy-assisted total gastrectomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026