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

Gastrectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01142271
• Other study ID #: AJIRB-MED-DEO-09-297
• Status: Recruiting
• Phase: Phase 3
• First received: June 8, 2010
• Last updated: November 4, 2011
• Start date: June 2010
• Est. completion date: May 2012

Study information

• Verified date: November 2011
• Source: Ajou University School of Medicine
• Contact: Hoon Hur, M.D.
• Phone: +82-31-219-2507
• Email: hhcmc75[@]naver.com
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Gastrectomy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. Epub 2007 Sep 18. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Morbidity	We investigate the occurrence of complication during recovery after surgery.	2 month after surgery	Yes
Secondary	Anastomotic time	We estimate anastomosis time	Day 1	No
Secondary	Nutritional state	We estimate Albumin, transferrin, lymphocyte, body weight	6 month after surgery	No
Secondary	Mortality	We investigate the occurrence of operation-related death during recovery after surgery.	2 month after operation	Yes
Secondary	Operation time	We estimate total operation time.	Day 1	No

External Links

•   Ajou University Hospital, Regional Clinical Trial Center
•   Ajou University School of Medicine, Hospital