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

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

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

Study Overview

• Status: Unknown
• Conditions: Gastrectomy
• Intervention / Treatment: Procedure: Billroth-I; Procedure: Roux en Y

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Suwon, Korea, Republic of, 422-749
    • Recruiting
    • Ajou University Hospital
    • Contact: Hoon Hur, M.D.; Phone Number: +82-31-219-5207; Email: hhcmc75@naver.com
    • Contact: Jun Young Kim, M.D.; Phone Number: +82-31-219-5206; Email: murmur2@hanmail.net
    • Principal Investigator: Sang-Uk Han, M.D., Ph.D.
    • Sub-Investigator: Hoon Hur, M.D.
    • Sub-Investigator: Young Bae Kim, M.D.
    • Sub-Investigator: Jun Young Kim, M.D.
    • Sub-Investigator: Sun Mi Uhm, N.R.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Billroth-I; Patients in this group should be underwent gastroduodenostomy as reconstruction procedure after standard distal subtotal gastrectomy with lymph node dissection.	Procedure: Billroth-I; Standard distal gastrectomy with D1 plus beta or D2 lymph node dissection would be performed for distal gastric cancer. After that, gastroduodenostomy should be performed by circular stapler. In addition, stapler sites were re-enforced.; Other Names: Gastroduodenostomy
Experimental: Roux en Y; Patients in this group should be underwent jejunojejunostomy and gastrojejunostomy as reconstruction procedure after standard distal gastrectomy.	Procedure: Roux en Y; Standard distal gastrectomy with D1 plus beta or D2 lymph node dissection would be performed for distal gastric cancer. After that, jejunojejunostomy and gastrojejunostomy should be performed by circular staplers. In addition, stapler sites were re-enforced.; Other Names: Gastrojejunostomy and jejunojejunostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reflux of bile content	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.	6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	We investigate the quality of life with EORTC-C30, EORTC-STO22 questionnaire suggested by European Organization for Research and Treatment of Cancer (EORTC).	6 months after surgery
Morbidity	We investigate the occurrence of complication during recovery after surgery.	2 month after surgery
Anastomotic time	We estimate anastomosis time	Day 1
Nutritional state	We estimate Albumin, transferrin, lymphocyte, body weight	6 month after surgery
Mortality	We investigate the occurrence of operation-related death during recovery after surgery.	2 month after operation
Operation time	We estimate total operation time.	Day 1

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine
• Investigators: Principal Investigator: Sang-Uk Han, M.D., Ph D., Department of surgery, Ajou University School of Medicine; Study Director: Hoon Hur, M.D., Department of surgery, Ajou University School of Medicine

Publications and helpful links

General Publications

• Chan DC, Fan YM, Lin CK, Chen CJ, Chen CY, Chao YC. Roux-en-Y reconstruction after distal gastrectomy to reduce enterogastric reflux and Helicobacter pylori infection. J Gastrointest Surg. 2007 Dec;11(12):1732-40. doi: 10.1007/s11605-007-0302-0. Epub 2007 Sep 18.
• Ishikawa M, Kitayama J, Kaizaki S, Nakayama H, Ishigami H, Fujii S, Suzuki H, Inoue T, Sako A, Asakage M, Yamashita H, Hatono K, Nagawa H. Prospective randomized trial comparing Billroth I and Roux-en-Y procedures after distal gastrectomy for gastric carcinoma. World J Surg. 2005 Nov;29(11):1415-20; discussion 1421. doi: 10.1007/s00268-005-7830-0.
• Nishizaki D, Ganeko R, Hoshino N, Hida K, Obama K, Furukawa TA, Sakai Y, Watanabe N. Roux-en-Y versus Billroth-I reconstruction after distal gastrectomy for gastric cancer. Cochrane Database Syst Rev. 2021 Sep 15;9:CD012998. doi: 10.1002/14651858.CD012998.pub2. Review.
• Hur H, Ahn CW, Byun CS, Shin HJ, Kim YB, Son SY, Han SU. A Novel Roux-en-Y Reconstruction Involving the Use of Two Circular Staplers after Distal Subtotal Gastrectomy for Gastric Cancer. J Gastric Cancer. 2017 Sep;17(3):255-266. doi: 10.5230/jgc.2017.17.e32. Epub 2017 Sep 26.

Helpful Links

• Ajou University School of Medicine, Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Anticipated): May 1, 2012
• Study Completion (Anticipated): May 1, 2012

Study Registration Dates

• First Submitted: June 8, 2010
• First Submitted That Met QC Criteria: June 10, 2010
• First Posted (Estimate): June 11, 2010

Study Record Updates

• Last Update Posted (Estimate): November 6, 2011
• Last Update Submitted That Met QC Criteria: November 4, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Distal gastrectomy; Reconstruction; Reflux; subtotal gastrectomy
• Other Study ID Numbers: AJIRB-MED-DEO-09-297

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No