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Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Tianjin Medical University Cancer Institute and Hospital.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01744938
First Posted: December 7, 2012
Last Update Posted: December 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital
  Purpose
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.

Condition Intervention Phase
Postoperative Complications Procedure: preoperative biliary drainage Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice: A Phase III, Randomized, Controlled, Single Center Study.

Resource links provided by NLM:


Further study details as provided by Tianjin Medical University Cancer Institute and Hospital:

Primary Outcome Measures:
  • the difference in postoperative morbidity [ Time Frame: 12 weeks postoperation ]
    the difference in postoperative morbidity between two groups (preoperative biliary drainage or early surgery (without preoperative biliary drainage))


Estimated Enrollment: 136
Study Start Date: September 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: early surgery
only receiving pancreaticoduodenectomy without preoperative biliary drainage
Experimental: preoperative biliary drainage
percutaneous preoperative biliary drainage before pancreaticoduodenectomy guided by CT scan
Procedure: preoperative biliary drainage
percutaneous preoperative biliary drainage guided by CT

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01744938


Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Investigators
Principal Investigator: Song Tian qiang, doctor Tianjin Medical University Cancer Institute and Hospital
  More Information

Additional Information:
Publications:
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.
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. Review.
Saleh MM, Nørregaard P, Jørgensen 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.
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. Review. Update in: Cochrane Database Syst Rev. 2012;9:CD005444.
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.
Tomazic A, Pleskovic A. Surgical outcome after pancreatoduodenectomy: effect of preoperative biliary drainage. Hepatogastroenterology. 2006 Nov-Dec;53(72):944-6.
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.
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. Review.
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. Review.
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;(3):CD006001. Review.

Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT01744938     History of Changes
Other Study ID Numbers: CIH-STQ-201205001
First Submitted: December 5, 2012
First Posted: December 7, 2012
Last Update Posted: December 22, 2015
Last Verified: May 2012

Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
Postoperative Complications,
mortality,
length of Stay,
economics

Additional relevant MeSH terms:
Postoperative Complications
Jaundice
Jaundice, Obstructive
Pathologic Processes
Hyperbilirubinemia
Skin Manifestations
Signs and Symptoms


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