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

Phase 3

Terminated

• Conditions: Gastric Cancer
• Interventions: Procedure: Laparoscopy-assisted gastrectomy

• Registration Number: NCT01433861
• Lead Sponsor: Seoul National University Bundang Hospital

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-09-10
• Study First Submitted QC: 2011-09-13
• Study First Posted: 2011-09-14
• Study Start: 2012-07
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-06
• Last Update Posted: 2017-01-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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)

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LAPG	Laparoscopy-assisted gastrectomy	LAPG : laparoscopy-assisted proximal gastrectomy with double tract reconstruction group
LATG	Laparoscopy-assisted gastrectomy	LATG : laparoscopy-assisted total gastrectomy group

Primary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyenggi, Korea, Republic of