A Trial of Reconstruction After Distal Gastrectomy for Gastric Cancer
NCT ID: NCT01065688
Last Updated: 2018-10-09
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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COMPLETED
PHASE3
120 participants
INTERVENTIONAL
2009-01-31
2013-11-30
Brief Summary
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Detailed Description
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The primary endpoint was the postoperative QOL. The secondary endpoints were the incidence of postoperative complications, nutritional status, and the incidence of the remnant gastritis and the reflux esophagitis. Patients were recruited into this study before surgery, on the basis of whether distal gastrectomy was anticipated at Wakayama Medical University Hospital(WMUH) for gastric cancer, and appropriate informed consent was obtained. Exclusion criteria was 1) patients with severe complications which were possible to prolong hospital stay, 2) patients with history of other organ malignancies, 3) patients who were diagnosed inadequacy for this study by a physician, and 4) patients without an informed consent.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Roux-en Y
Roux-en Y reconstruction after distal gastrectomy
Roux-en Y reconstruction
surgical procedure
Billroth-I
Billroth-I reconstruction after distal gastrectomy
Billroth-I reconstruction
surgical procedure
Interventions
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Roux-en Y reconstruction
surgical procedure
Billroth-I reconstruction
surgical procedure
Eligibility Criteria
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Inclusion Criteria
* Performance status: Eastern Cooperative Oncology Group (ECOG) 0-1
* Tumor located in the antrum or the angle or the lower body of stomach
* Appropriate informed consent was obtained.
Exclusion Criteria
* Patients with history of other organ malignancies
* Patients who were diagnosed inadequacy for this study by a physician
* Patients without an informed consent
20 Years
80 Years
ALL
No
Sponsors
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Wakayama Medical University
OTHER
Responsible Party
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Hiroki Yamaue
Second Department of Surgery, Wakayama Medical University
Principal Investigators
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Masaki Nakamura, MD
Role: PRINCIPAL_INVESTIGATOR
Second Department of Surgery, Wakayama Medical University
Locations
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Second Department of Surgery, Wakayama Medical University
Wakayama, , Japan
Countries
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References
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Ojima T, Iwahashi M, Nakamori M, Nakamura M, Naka T, Katsuda M, Iida T, Tsuji T, Hayata K, Takifuji K, Yamaue H. Clinicopathological characteristics of remnant gastric cancer after a distal gastrectomy. J Gastrointest Surg. 2010 Feb;14(2):277-81. doi: 10.1007/s11605-009-1090-5.
Ojima T, Iwahashi M, Nakamori M, Nakamura M, Naka T, Katsuda M, Iida T, Hayata K, Yamaue H. Association of allogeneic blood transfusions and long-term survival of patients with gastric cancer after curative gastrectomy. J Gastrointest Surg. 2009 Oct;13(10):1821-30. doi: 10.1007/s11605-009-0973-9. Epub 2009 Aug 5.
Iwahashi M, Nakamori M, Nakamura M, Naka T, Ojima T, Iida T, Katsuda M, Ueda K, Yamaue H. Evaluation of double tract reconstruction after total gastrectomy in patients with gastric cancer: prospective randomized controlled trial. World J Surg. 2009 Sep;33(9):1882-8. doi: 10.1007/s00268-009-0109-0.
Ojima T, Iwahashi M, Nakamori M, Nakamura M, Naka T, Ishida K, Ueda K, Katsuda M, Iida T, Tsuji T, Yamaue H. Influence of overweight on patients with gastric cancer after undergoing curative gastrectomy: an analysis of 689 consecutive cases managed by a single center. Arch Surg. 2009 Apr;144(4):351-8; discussion 358. doi: 10.1001/archsurg.2009.20.
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.
Nakamura M, Nakamori M, Ojima T, Iwahashi M, Horiuchi T, Kobayashi Y, Yamade N, Shimada K, Oka M, Yamaue H. Randomized clinical trial comparing long-term quality of life for Billroth I versus Roux-en-Y reconstruction after distal gastrectomy for gastric cancer. Br J Surg. 2016 Mar;103(4):337-47. doi: 10.1002/bjs.10060. Epub 2016 Feb 3.
Other Identifiers
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WMU-GC03
Identifier Type: -
Identifier Source: org_study_id
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