Comparison of Billroth-I and Roux-en-Y Reconstruction After Distal Subtotal Gastrectomy
NCT ID: NCT01142271
Last Updated: 2011-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
120 participants
INTERVENTIONAL
2010-06-30
2012-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Billroth-I
Patients in this group should be underwent gastroduodenostomy as reconstruction procedure after standard distal subtotal gastrectomy with lymph node dissection.
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
Patients in this group should be underwent jejunojejunostomy and gastrojejunostomy as reconstruction procedure after standard distal gastrectomy.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 with uncontrolled disease
* Patient s with synchronous other malignancy
* Patients participated in other clinical trial
20 Years
75 Years
ALL
No
Sponsors
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Ajou University School of Medicine
OTHER
Responsible Party
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Sang-Uk Han
Department of Surgery
Principal Investigators
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Sang-Uk Han, M.D., Ph D.
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery, Ajou University School of Medicine
Hoon Hur, M.D.
Role: STUDY_DIRECTOR
Department of Surgery, Ajou University School of Medicine
Locations
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Ajou University Hospital
Suwon, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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(9):CD012998. doi: 10.1002/14651858.CD012998.pub2.
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.
Other Identifiers
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AJIRB-MED-DEO-09-297
Identifier Type: -
Identifier Source: org_study_id