Randomized Controlled Trial on Pancreatic Stent Tube in Pancreaticoduodenectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective, Randomized, and Controlled Trial That Lost Stent Versus External Stent of Pancreaticojejunostomy After Pancreaticoduodenectomy

Conditions
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Pancreatic Cancer, Bile Duct Cancer, Ampullary Cancer, Pancreatitis, Duodenal Cancer

Intervention / Treatment
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* Device: external drainage tube [polyethylene pancreatic drainage tube]
* Device: internal drainage tube [polyethylene pancreatic drainage tube]


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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]<br>* 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.<br>* Other names: polyethylene pancreatic drainage tube(S/N MD41515);Device: internal drainage tube [polyethylene pancreatic drainage tube]<br>* 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.<br>* Other names: polyethylene pancreatic drainage tube(S/N MD41515);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the length of hospital stay after pancreaticoduodenectomy |  | the day of discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| early and late complications after pancreaticoduodenectomy |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreaticoduodenectomy, stent, pancreaticojejunostomy, hospital stay, complication, pancreatic fistula