Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice - Full Text View

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice: A Phase III, Randomized, Controlled, Single Center Study.

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 ] [ Designated as safety issue: No ]
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 2015
Estimated Primary Completion Date:	September 2015 (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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Tianjin Medical University Cancer Institute and Hospital This link exits the ClinicalTrials.gov site

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.

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. Review.

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. 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. 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
Study First Received:	December 5, 2012
Last Updated:	December 5, 2012
Health Authority:	China: Ethics Committee

Keywords provided by Tianjin Medical University Cancer Institute and Hospital:

Postoperative Complications,
mortality,
length of Stay,
economics

Additional relevant MeSH terms:

Jaundice
Jaundice, Obstructive
Postoperative Complications
Hyperbilirubinemia

Pathologic Processes
Skin Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013