Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice
This study is enrolling participants by invitation only.
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier:
NCT01744938
First received: December 5, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
| Tracking Information | |||||
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| First Received Date ICMJE | December 5, 2012 | ||||
| Last Updated Date | December 5, 2012 | ||||
| Start Date ICMJE | September 2012 | ||||
| Estimated Primary Completion Date | September 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
the difference in postoperative morbidity [ Time Frame: 12 weeks postoperation ] [ Designated as safety issue: No ] the difference in postoperative morbidity between two groups (preoperative biliary drainage or early surgery (without preoperative biliary drainage)) |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice | ||||
| Official Title ICMJE | Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice: A Phase III, Randomized, Controlled, Single Center Study. | ||||
| Brief Summary | Patients with the lower malignant obstructive jaundice planned to do the pancreaticoduodenectomy, receiving preoperative biliary drainage or early surgery (without preoperative biliary drainage), both groups has the similar surgical morbidity, no statistics significance. |
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| Detailed Description | Patients with the lower malignant obstructive jaundice divided into two groups:early surgery, preoperative biliary drainage + surgery. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Postoperative Complications | ||||
| Intervention ICMJE | Procedure: preoperative biliary drainage
percutaneous preoperative biliary drainage guided by CT |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 136 | ||||
| Estimated Completion Date | December 2015 | ||||
| Estimated Primary Completion Date | September 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01744938 | ||||
| Other Study ID Numbers ICMJE | CIH-STQ-201205001 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Tianjin Medical University Cancer Institute and Hospital | ||||
| Study Sponsor ICMJE | Tianjin Medical University Cancer Institute and Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Tianjin Medical University Cancer Institute and Hospital | ||||
| Verification Date | May 2012 | ||||
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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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