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Randomized Controlled Trial on Pancreatic Stent Tube in Pancreaticoduodenectomy
This study is ongoing, but not recruiting participants.
Study NCT00628186   Information provided by Wakayama Medical University
First Received: January 23, 2008   Last Updated: March 3, 2008   History of Changes

January 23, 2008
March 3, 2008
April 2005
August 2007   (final data collection date for primary outcome measure)
the length of hospital stay after pancreaticoduodenectomy [ Time Frame: the day of discharge ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00628186 on ClinicalTrials.gov Archive Site
early and late complications after pancreaticoduodenectomy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
 
Randomized Controlled Trial on Pancreatic Stent Tube in Pancreaticoduodenectomy
Prospective, Randomized, and Controlled Trial That Lost Stent Versus External Stent of Pancreaticojejunostomy After Pancreaticoduodenectomy

The purpose of this study is to determine which stent type is effective in the decrease of postoperative stay and complications across pancreaticojejunostomy after pancreaticoduodenectomy.

This study compared the postoperative hospital stay and complications of lost stent with external stent after pancreaticoduodenectomy. The complications of pancreaticoduodenectomy are important to affect the postoperative course, and, a stent tube often places across pancreaticojejunostomy to reduce complications. However, there is no report that demonstrates the postoperative course between pancreatic stent types. We conducted a prospective randomized trial on 100 patients who underwent pancreaticoduodenectomy comparing external stent and lost stent.

The primary endpoint was defined as postoperative hospital stay. The secondary endpoints were mortality and morbidity, including pancreatic fistula, delayed gastric emptying, intra-abdominal hemorrhage, and intra-abdominal abscess. Patients were recruited into this study before surgery, on the basis of whether pancreatic head resection was anticipated at WMUH for pancreatic head and periampullary disease, and appropriate informed consent was obtained. Exclusion criteria was 1) patients with severe complications which were possible to prolong hospital stay, 2) patients who were diagnosed inadequacy for this study by a physician, 3) patients who could not be placed a pancreatic stent tube, and 4) patients without an informed consent.

 
Interventional
Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
  • Pancreatic Cancer
  • Bile Duct Cancer
  • Ampullary Cancer
  • Pancreatitis
  • Duodenal Cancer
  • Device: external drainage tube [polyethylene pancreatic drainage tube]
  • Device: internal drainage tube [polyethylene pancreatic drainage tube]
Experimental: Pancreaticojejunostomy has a risk factor of pancreatic fistula. Type of stent tube (external stent vs. short stent)across pancreaticojejunostomy was randomized for the patients with pancreaticoduodenectomy.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
100
February 2008
August 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • On the basis of whether pancreatic head resection was anticipated at WMUH for pancreatic head and periampullary disease, and appropriate informed consent was obtained.

Exclusion Criteria:

  • Patients with severe complications which were possible to prolong hospital stay
  • Patients who were diagnosed inadequacy for this study by a physician
  • Patients who could not be placed a pancreatic stent tube
  • Patients without an informed consent.
Both
 
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00628186
Second Department of Surgery, Wakayama Medical University
WP-0501
Wakayama Medical University
 
Study Director: Masaji Tani, MD Wakayama Medical University, Second Department of Surgery
Wakayama Medical University
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP