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

Seoul National University

Status and phase: Terminated; Phase 3

Conditions: Gastric Cancer

Treatments: Procedure: Laparoscopy-assisted gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01433861

SNUBHGS

Details and patient eligibility

About

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

Full 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

Enrollment: 7 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

LAPG

Active Comparator group

Description:

LAPG : laparoscopy-assisted proximal gastrectomy with double tract reconstruction group

Treatment:

Procedure: Laparoscopy-assisted gastrectomy

LATG

Active Comparator group

Description:

LATG : laparoscopy-assisted total gastrectomy group

Treatment:

Procedure: Laparoscopy-assisted gastrectomy