An interventional study of external drainage tube [polyethylene pancreatic drainage tube] and internal drainage tube [polyethylene pancreatic drainage tube] in Pancreatic Cancer, Bile Duct Cancer and Ampullary Cancer, sponsored by Wakayama Medical University. Completed at 1 site in Japan. Per ClinicalTrials.gov, last updated 2010-01-18.
Sponsored by Wakayama Medical University · Not applicable, Interventional, and Treatment
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.
217 studies on the registry are indexed under Bile Duct Neoplasms; 43 are open to participants now.
This study's enrollment of 100 is above the median of 50 across 161 interventional studies indexed under Bile Duct Neoplasms.
Browse Bile Duct Neoplasms studies →Wakayama Medical University is the lead sponsor of 25 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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] · Device: internal 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.
Also known as: polyethylene pancreatic drainage tube(S/N MD41515)
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.
Also known as: 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
This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.
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Wakayama Medical University