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NCT01744938 Clinical Trial

Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice

Postoperative Complications Clinical Trial

Official title:
Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice: A Phase III, Randomized, Controlled, Single Center Study.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT01744938
Other study ID # CIH-STQ-201205001
Secondary ID
Status Enrolling by invitation
Phase Phase 3
First received December 5, 2012
Last updated December 21, 2015
Start date September 2012
Est. completion date December 2016

Study information
Verified date May 2012
Source Tianjin Medical University Cancer Institute and Hospital
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 136
Est. completion date December 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• preoperative biliary drainage
percutaneous preoperative biliary drainage guided by CT

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Tianjin Medical University Cancer Institute and Hospital

References & Publications (10)

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. — View 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;(3):CD006001. Review. — View 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. — View Citation

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. — View 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. Review. — View Citation

Tomazic A, Pleskovic A. Surgical outcome after pancreatoduodenectomy: effect of preoperative biliary drainage. Hepatogastroenterology. 2006 Nov-Dec;53(72):944-6. — View 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, — View 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 20 — View 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 o — View 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. Review. Update in: Cochrane Database Syst Rev. 2012;9:CD005444. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary the difference in postoperative morbidity the difference in postoperative morbidity between two groups (preoperative biliary drainage or early surgery (without preoperative biliary drainage)) 12 weeks postoperation No
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