Clinical trial NCT01433861: Laparoscopy-assisted Proximal Gastrectomy Versus and Laparoscopy-assisted Total Gastrectomy
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: gastric cancer
proximal gastrectomy
total gastrectomy
laparoscopy
reflux esophagitis
double tract reconstruction
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2011-09-14
Enrollment: 7
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: Rate of reflux esophagitis
timeFrame: postoperative 3 month
measure: Rate of reflux esophagitis
timeFrame: postoperative 6 month
measure: Rate of reflux esophagitis
timeFrame: postoperative 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyenggi
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Hyung-Ho Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: