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Comparison of Billroth-I and Roux-en-Y Reconstruction After Distal Subtotal Gastrectomy for Gastric Cancer Patients : Prospective Randomized Study


Phase 3
20 Years
75 Years
Open (Enrolling)
Both
Gastrectomy

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Trial Information

Comparison of Billroth-I and Roux-en-Y Reconstruction After Distal Subtotal Gastrectomy for Gastric Cancer Patients : Prospective Randomized Study


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

Reflux of bile content

Outcome Description:

We estimate the degree of reflux by gastrofiberscopic findings using reflux score suggested by Romaganoli. In addition, histological finding of remnant stomach by endoscopic biopsy is also investigated. Reflux symptom is surveyed by Gastrointestinal Symptom Rating Scale.

Outcome Time Frame:

6 months after surgery

Safety Issue:

No

Principal Investigator

Sang-Uk Han, M.D., Ph D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Surgery, Ajou University School of Medicine

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

AJIRB-MED-DEO-09-297

NCT ID:

NCT01142271

Start Date:

June 2010

Completion Date:

May 2012

Related Keywords:

  • Gastrectomy
  • Distal gastrectomy
  • Reconstruction
  • Reflux
  • subtotal gastrectomy

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