Comparison of Billroth-I and Roux-en-Y Reconstruction After Distal Subtotal Gastrectomy

A

Ajou University School of Medicine

Status and phase

Unknown
Phase 3

Conditions

Gastrectomy

Treatments

Procedure: Roux en Y
Procedure: Billroth-I

Study type

Interventional

Funder types

Other

Identifiers

NCT01142271
AJIRB-MED-DEO-09-297

Details and patient eligibility

About

The purpose of this trial is to compare the degree of reflux, operative outcomes and quality of life between Roux en Y and Billroth-I reconstructions after distal subtotal gastrectomy for gastric cancer

Full description

Most common procedure for the resection of gastric cancers located in middle or lower stomach is distal subtotal gastrectomy. However, the optimal reconstruction procedure after that has still not to be established. Although B-I reconstruction is most common method due to the safety and simplicity, the duodenal fluid may reflux into the remnant stomach which may contribute to the mucosal injury to remnant stomach and esophagus. Roux en Y reconstruction may reduce the reflux to remnant stomach due to the length of Roux en Y limb, although it is more complicated procedure. Therefore, we plan to collect 120 patients to compare the degree of reflux between Roux en Y and Billroth-I reconstructions after distal subtotal gastrectomy for gastric cancer. In addition, we compare the surgical outcome and quality of life between two groups.

Enrollment

120 estimated patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients diagnosed with adenocarcinoma at the endoscopic biopsy
  • Patients who are possible to be performed curative resection in imaging study
  • Patients with tumor which not involved in pylorus and are located in mid or distal portion of the stomach
  • Patients with informed consent
  • Patients with three or less American Society Anesthesiology Score 3

Exclusion criteria

  • Patients who are or become pregnant
  • Patients with uncontrolled disease
  • Patient s with synchronous other malignancy
  • Patients participated in other clinical trial

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

120 participants in 2 patient groups

Billroth-I
Experimental group
Description:
Patients in this group should be underwent gastroduodenostomy as reconstruction procedure after standard distal subtotal gastrectomy with lymph node dissection.
Treatment:
Procedure: Billroth-I
Roux en Y
Experimental group
Description:
Patients in this group should be underwent jejunojejunostomy and gastrojejunostomy as reconstruction procedure after standard distal gastrectomy.
Treatment:
Procedure: Roux en Y

Trial contacts and locations

0

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Central trial contact

Hoon Hur, M.D.; Sang-Uk Han, M.D.

Data sourced from clinicaltrials.gov

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