Randomized Controlled Trial on Pancreatic Stent Tube in Pancreaticoduodenectomy
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|ClinicalTrials.gov Identifier: NCT00628186|
Recruitment Status : Completed
First Posted : March 4, 2008
Last Update Posted : January 18, 2010
|Condition or disease||Intervention/treatment||Phase|
|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]||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Randomized, and Controlled Trial That Lost Stent Versus External Stent of Pancreaticojejunostomy After Pancreaticoduodenectomy|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||August 2007|
|Actual Study Completion Date :||February 2008|
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.
Device: external drainage tube [polyethylene pancreatic drainage tube]
External drainage tube was intubated with a 5F polyethylene pancreatic drainage tube with a small knob (Sumitomo Bakelite Co., Japan)(MD41515) across pancreaticojejunostomy in pancreaticoduodenectomy, and exteriorized through the jejunal limb.
Other Name: polyethylene pancreatic drainage tube(S/N MD41515)Device: internal drainage tube [polyethylene pancreatic drainage tube]
Internal drainage tube was intubated 5cm length of stent tube cut a 5F polyethylene pancreatic drainage tube with a small knob across pancreaticojejunostomy in pancreaticoduodenectomy, and pancreatic juice was led to reconstructed jejunum.
Other Name: polyethylene pancreatic drainage tube(S/N MD41515)
- the length of hospital stay after pancreaticoduodenectomy [ Time Frame: the day of discharge ]
- early and late complications after pancreaticoduodenectomy [ Time Frame: 6 months ]
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): NCT00628186
|Wakayama Medical University , Second Department of Surgery|
|811-1 Kimiidera, Wakayama, Wakayama, Japan, 641-8510|
|Study Director:||Masaji Tani, MD||Wakayama Medical University, Second Department of Surgery|