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Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice

Primary Purpose

Postoperative Complications

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
preoperative biliary drainage
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Complications focused on measuring Postoperative Complications,, mortality,, length of Stay,, economics

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with the lower malignant obstructive jaundice
  • Total bilirubin: 150-350 umol/L

Exclusion Criteria:

  • age less than 18
  • emergency operation
  • biliary tract stent placed
  • past history of operation on pancreas
  • intraoperative unresectable tumor with pancreaticoduodenectomy
  • unresectable tumor or potential resectable tumor with pancreaticoduodenectomy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    early surgery

    preoperative biliary drainage

    Arm Description

    only receiving pancreaticoduodenectomy without preoperative biliary drainage

    percutaneous preoperative biliary drainage before pancreaticoduodenectomy guided by CT scan

    Outcomes

    Primary Outcome Measures

    the difference in postoperative morbidity
    the difference in postoperative morbidity between two groups (preoperative biliary drainage or early surgery (without preoperative biliary drainage))

    Secondary Outcome Measures

    Full Information

    First Posted
    December 5, 2012
    Last Updated
    December 21, 2015
    Sponsor
    Tianjin Medical University Cancer Institute and Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01744938
    Brief Title
    Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice
    Official Title
    Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice: A Phase III, Randomized, Controlled, Single Center Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2012
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2012 (undefined)
    Primary Completion Date
    November 2016 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tianjin Medical University Cancer Institute and Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    Patients with the lower malignant obstructive jaundice divided into two groups:early surgery, preoperative biliary drainage + surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Complications
    Keywords
    Postoperative Complications,, mortality,, length of Stay,, economics

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    136 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    early surgery
    Arm Type
    No Intervention
    Arm Description
    only receiving pancreaticoduodenectomy without preoperative biliary drainage
    Arm Title
    preoperative biliary drainage
    Arm Type
    Experimental
    Arm Description
    percutaneous preoperative biliary drainage before pancreaticoduodenectomy guided by CT scan
    Intervention Type
    Procedure
    Intervention Name(s)
    preoperative biliary drainage
    Intervention Description
    percutaneous preoperative biliary drainage guided by CT
    Primary Outcome Measure Information:
    Title
    the difference in postoperative morbidity
    Description
    the difference in postoperative morbidity between two groups (preoperative biliary drainage or early surgery (without preoperative biliary drainage))
    Time Frame
    12 weeks postoperation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with the lower malignant obstructive jaundice Total bilirubin: 150-350 umol/L Exclusion Criteria: age less than 18 emergency operation biliary tract stent placed past history of operation on pancreas intraoperative unresectable tumor with pancreaticoduodenectomy unresectable tumor or potential resectable tumor with pancreaticoduodenectomy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Song Tian qiang, doctor
    Organizational Affiliation
    Tianjin Medical University Cancer Institute and Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17636818
    Citation
    Mumtaz K, Hamid S, Jafri W. Endoscopic retrograde cholangiopancreaticography with or without stenting in patients with pancreaticobiliary malignancy, prior to surgery. Cochrane Database Syst Rev. 2007 Jul 18;2007(3):CD006001. doi: 10.1002/14651858.CD006001.pub2.
    Results Reference
    background
    PubMed Identifier
    20071702
    Citation
    van der Gaag NA, Rauws EA, van Eijck CH, Bruno MJ, van der Harst E, Kubben FJ, Gerritsen JJ, Greve JW, Gerhards MF, de Hingh IH, Klinkenbijl JH, Nio CY, de Castro SM, Busch OR, van Gulik TM, Bossuyt PM, Gouma DJ. Preoperative biliary drainage for cancer of the head of the pancreas. N Engl J Med. 2010 Jan 14;362(2):129-37. doi: 10.1056/NEJMoa0903230.
    Results Reference
    result
    PubMed Identifier
    12131081
    Citation
    Sewnath ME, Karsten TM, Prins MH, Rauws EJ, Obertop H, Gouma DJ. A meta-analysis on the efficacy of preoperative biliary drainage for tumors causing obstructive jaundice. Ann Surg. 2002 Jul;236(1):17-27. doi: 10.1097/00000658-200207000-00005.
    Results Reference
    result
    PubMed Identifier
    12297769
    Citation
    Saleh MM, Norregaard P, Jorgensen HL, Andersen PK, Matzen P. Preoperative endoscopic stent placement before pancreaticoduodenectomy: a meta-analysis of the effect on morbidity and mortality. Gastrointest Endosc. 2002 Oct;56(4):529-34. doi: 10.1067/mge.2002.128161.
    Results Reference
    result
    PubMed Identifier
    18677779
    Citation
    Wang Q, Gurusamy KS, Lin H, Xie X, Wang C. Preoperative biliary drainage for obstructive jaundice. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD005444. doi: 10.1002/14651858.CD005444.pub2.
    Results Reference
    result
    PubMed Identifier
    17352805
    Citation
    van der Gaag NA, de Castro SM, Rauws EA, Bruno MJ, van Eijck CH, Kuipers EJ, Gerritsen JJ, Rutten JP, Greve JW, Hesselink EJ, Klinkenbijl JH, Rinkes IH, Boerma D, Bonsing BA, van Laarhoven CJ, Kubben FJ, van der Harst E, Sosef MN, Bosscha K, de Hingh IH, Th de Wit L, van Delden OM, Busch OR, van Gulik TM, Bossuyt PM, Gouma DJ. Preoperative biliary drainage for periampullary tumors causing obstructive jaundice; DRainage vs. (direct) OPeration (DROP-trial). BMC Surg. 2007 Mar 12;7:3. doi: 10.1186/1471-2482-7-3.
    Results Reference
    result
    PubMed Identifier
    17153458
    Citation
    Tomazic A, Pleskovic A. Surgical outcome after pancreatoduodenectomy: effect of preoperative biliary drainage. Hepatogastroenterology. 2006 Nov-Dec;53(72):944-6.
    Results Reference
    result
    PubMed Identifier
    11420482
    Citation
    Pisters PW, Hudec WA, Hess KR, Lee JE, Vauthey JN, Lahoti S, Raijman I, Evans DB. Effect of preoperative biliary decompression on pancreaticoduodenectomy-associated morbidity in 300 consecutive patients. Ann Surg. 2001 Jul;234(1):47-55. doi: 10.1097/00000658-200107000-00008.
    Results Reference
    result
    PubMed Identifier
    18726134
    Citation
    van der Gaag NA, Kloek JJ, de Castro SM, Busch OR, van Gulik TM, Gouma DJ. Preoperative biliary drainage in patients with obstructive jaundice: history and current status. J Gastrointest Surg. 2009 Apr;13(4):814-20. doi: 10.1007/s11605-008-0618-4. Epub 2008 Aug 23.
    Results Reference
    result
    PubMed Identifier
    19940799
    Citation
    Garcea G, Chee W, Ong SL, Maddern GJ. Preoperative biliary drainage for distal obstruction: the case against revisited. Pancreas. 2010 Mar;39(2):119-26. doi: 10.1097/MPA.0b013e3181bd65de.
    Results Reference
    result
    Links:
    URL
    http://www.tjmuch.com/
    Description
    Tianjin Medical University Cancer Institute and Hospital

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    Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice

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