Randomized Controlled Trial on Pancreatic Stent Tube in Pancreaticoduodenectomy

Not Applicable

Completed

• Conditions: Bile Duct Cancer; Pancreatitis; Duodenal Cancer; Pancreatic Cancer; Ampullary Cancer
• Interventions: Device: external drainage tube [polyethylene pancreatic drainage tube]; Device: internal drainage tube [polyethylene pancreatic drainage tube]

• Registration Number: NCT00628186
• Lead Sponsor: Wakayama Medical University

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2005-04
• Primary Completion: 2007-08
• Study First Submitted: 2008-01-23
• Study Completion: 2008-02
• Study First Submitted QC: 2008-03-03
• Study First Posted: 2008-03-04
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-15
• Last Update Posted: 2010-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	internal drainage tube [polyethylene pancreatic drainage tube]	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.
1	external drainage tube [polyethylene pancreatic drainage tube]	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.

Primary Outcome Measures

Name	Time	Method
the length of hospital stay after pancreaticoduodenectomy	the day of discharge

Secondary Outcome Measures

Name	Time	Method
early and late complications after pancreaticoduodenectomy	6 months

Trial Locations

Locations (1)

Wakayama Medical University , Second Department of Surgery; 🇯🇵 811-1 Kimiidera, Wakayama, Wakayama, Japan