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

Gastric Cancer Clinical Trial

— PRAPT  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01433861
• Other study ID #: SNUBHGS
• Status: Terminated
• Phase: Phase 3
• First received: September 10, 2011
• Last updated: January 6, 2017
• Start date: July 2012
• Est. completion date: November 2012

Study information

• Verified date: January 2017
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Laparoscopy-assisted gastrectomy
Laparoscopy-assisted proximal gastrectomy versus Laparoscopy-assisted total gastrectomy

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyenggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of reflux esophagitis	Comprehesive evaulation by 24hr pH monitoring, DISIDA scan, Endoscopic evaluation according to LA classification and Visick score	postoperative 3 month	Yes
Primary	Rate of reflux esophagitis	Comprehesive evaulation by 24hr pH monitoring, DISIDA scan, Endoscopic evaluation according to LA classification and Visick score	postoperative 6 month	Yes
Primary	Rate of reflux esophagitis	Comprehesive evaulation by 24hr pH monitoring, DISIDA scan, Endoscopic evaluation according to LA classification and Visick score	postoperative 12 month	Yes