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| Tracking Information | |||||
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| First Received Date ICMJE | March 14, 2008 | ||||
| Last Updated Date | February 18, 2009 | ||||
| Start Date ICMJE | October 2005 | ||||
| Primary Completion Date | October 2005 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
delayed gastric empty after pancreaticoduodenectomy [ Time Frame: 1 month ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00639314 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
evaluation of quality of life, early and late complications after pancreaticoduodenectomy [ Time Frame: 2 years ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Trial on the Evaluation of Pylorus-Ring in Pancreaticoduodenectomy | ||||
| Official Title ICMJE | Randomized Controlled Trial on the Evaluation of Pylorus-Ring in Pancreaticoduodenectomy | ||||
| Brief Summary | The purpose of this study is to clarify whether resecting pylorus-ring decreases delayed gastric emptying after pancreaticoduodenectomy and improves postoperative quality of life (QOL). |
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| Detailed Description | The purpose of this study is to clarify whether resecting pylorus-ring decreases delayed gastric emptying after pancreaticoduodenectomy and improves postoperative quality of life(QOL)compared with preserving pylorus-ring. Delayed gastric emptying after pancreaticoduodenectomy are important to affect the postoperative course and QOL. However, there is no report that demonstrates the postoperative course between resecting pylorus-ring and preserving pylorus-ring. We conducted a prospective randomized trial on 130 patients who underwent pancreaticoduodenectomy comparing resecting pylorus-ring and preserving pylorus-ring. The primary endpoint was defined as the decrease of delayed gastric emptying. The secondary endpoints were QOL, mortality and morbidity, including pancreatic fistula, intra-abdominal hemorrhage, and intra-abdominal abscess. Patients were recruited into this study before surgery, on the basis of whether pancreatic head resection was anticipated at Wakayama Medical University Hospital(WMUH) for pancreatic head and periampullary disease, and appropriate informed consent was obtained. Exclusion criteria was 1) patients with severe complications which were possible to prolong hospital stay, 2) patients who were diagnosed inadequacy for this study by a physician, 3) patients with a previous gastric resection, and 4) patients without an informed consent. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 130 | ||||
| Estimated Completion Date | March 2009 | ||||
| Primary Completion Date | October 2005 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Japan | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00639314 | ||||
| Responsible Party | Second Department of Surgery, Wakayama Medical University | ||||
| Study ID Numbers ICMJE | WP-0502 | ||||
| Study Sponsor ICMJE | Wakayama Medical University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Wakayama Medical University | ||||
| Verification Date | February 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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