Prospective, Randomized, and Controlled Trial That Lost Stent Versus External Stent of 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
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
the length of hospital stay after pancreaticoduodenectomy
the day of discharge
Yes
Masaji Tani, MD
Study Director
Wakayama Medical University, Second Department of Surgery
Japan: Ministry of Health, Labor and Welfare
WP-0501
NCT00628186
April 2005
February 2008
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