Preoperative biliary drainage with metal stent.|
|- candidate number||10527|
|- NTR Number||NTR3142|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-nov-2011|
|- Secondary IDs||W11_82 METC AMC|
|- Public Title||Preoperative biliary drainage with metal stent.|
|- Scientific Title||Preoperative biliary drainage with metal stent in resectable periampullary cancer.|
|- hypothesis||Preoperative biliary drainage with metal stent in patients with resectable periampullary cancer results in less stent-related and drainage-related complications when compared to preoperative biliary drainage with plastic stents.|
|- Healt Condition(s) or Problem(s) studied||Pancreatic cancer, Periampullary tumor, Jaundice|
|- Inclusion criteria||1. Clinical diagnosis of obstructive jaundice due to a pancreatic head or periampullary tumor;|
2. A serum bilirubin level of > 40 Ámol/l and < 250 Ámol/l before inclusion;
3. A spiral CT scan according to standard protocol without metastases or local tumor ingrowth in the portal or mesenteric vessels of >180 degrees;
4. Scheduled for preoperative biliary drainage by principal physician;
5. Scheduled for surgical treatment in one of the participating centres.
|- Exclusion criteria||1. Age > 85 years or severe co-morbidity (Karnofsky <50%) and other contra indications for major surgery;|
3. Previous ERCP and stenting or percutaneous biliary drainage;
4. Previous chemotherapy for this malignancy;
5. Severe gastric outlet obstruction (stenosis duodenum due to tumor growth) defined as vomiting, nausea and/or oral intake less than one l/day.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-nov-2011|
|- planned closingdate||1-jun-2013|
|- Target number of participants||102|
|- Interventions||ERCP with placement of metal stent instead of plastic stent in jaundiced patients with resectable periampullary cancer.|
|- Primary outcome||The incidence of stent-related complications after preoperative biliary drainage with a metal stent. These results will be compared to those of the patients from the previous DROP trial (NTR NUMBER: NTR234) who underwent preoperative drainage with a plastic stent as well as patients without stenting.|
|- Secondary outcome||1. Hospital stay;|
2. Number of extra invasive diagnostic procedures;
4. Quality of Life.
These results will be compared to those of the patients from the previous DROP trial (NTR NUMBER: NTR234) who underwent preoperative drainage with a plastic stent as well as patients without stenting.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| J.A.M.G. Tol|
|- CONTACT for SCIENTIFIC QUERIES|| J.A.M.G. Tol|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Amsterdam|
|- Publications||Preoperative biliary drainage for cancer of the head of the pancreas.
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. N Engl J Med. 2010 Jan 14;362(2):129-37.
Therapeutic delay and survival after surgery for cancer of the pancreatic head with or without preoperative biliary drainage.
Eshuis WJ, van der Gaag NA, Rauws EA, van Eijck CH, Bruno MJ, Kuipers EJ, Coene PP, 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. Ann Surg. 2010 Nov;252(5):840-9.
Preoperative biliary drainage in patients with obstructive jaundice: history and current status.
van der Gaag NA, Kloek JJ, de Castro SM, Busch OR, van Gulik TM, Gouma DJ.
J Gastrointest Surg. 2009 Apr;13(4):814-20.
Preoperative biliary drainage for periampullary tumors causing obstructive jaundice; DRainage vs. (direct) OPeration (DROP-trial).
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. BMC Surg. 2007 Mar 12;7:3.
Delayed massive hemorrhage after pancreatic and biliary surgery: embolization or surgery? de Castro SM, Kuhlmann KF, Busch OR, van Delden OM, Lameris JS, van Gulik TM, Obertop H, Gouma DJ. Ann Surg. 2005 Jan;241(1):85-91.
A meta-analysis on the efficacy of preoperative biliary drainage for tumors causing obstructive jaundice.
Sewnath ME, Karsten TM, Prins MH, Rauws EJ, Obertop H, Gouma DJ. Ann Surg. 2002 Jul;236(1):17-27. |
|- Brief summary||Surgery in patients with obstructive jaundice caused by a periampullary (pancreas, papilla, distal bile duct) tumor is associated with a higher risk of postoperative complications then non-jaundiced patients. Preoperative biliary drainage (PBD) was introduced in an attempt to improve the general condition and thus reduce postoperative morbidity and mortality though different studies failed to report all the positive effects of drainage. In respect to the ongoing controversy of PBD a multicentre randomized controlled trial: DROP trial, was conducted comparing PBD followed by surgery, with surgery alone. Significantly more severe complications were reported in the preoperative drained patients. Many of these complications were stent related. It was concluded that early surgery should be performed in patients with a resectable periampullary tumor. For patients who still are selected for preoperative drainage due to waiting time, neo-adjuvant treatment or preoperative staging recent literature suggests the use of metal stents instead of plastic stents to initiate drainage. Metal stents have longer patency and occlude less often. Today still up to 60% of patients operated for resectable pancreatic cancer have been drained preoperative with plastic stents. We hypothesize that the use of metal stents in preoperative biliary drainage will be associated with lesser complications then preoperative biliary drainage with plastic stents and by that reduce overall complications of surgery.|
|- Main changes (audit trail)|
|- RECORD||14-nov-2011 - 26-nov-2011|
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