Randomized Controlled Trial on Pancreatic Stent Tube in Pancreaticoduodenectomy

This study has been completed.
Sponsor:
Information provided by:
Wakayama Medical University
ClinicalTrials.gov Identifier:
NCT00628186
First received: January 23, 2008
Last updated: January 15, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention
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]

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Randomized, and Controlled Trial That Lost Stent Versus External Stent of Pancreaticojejunostomy After Pancreaticoduodenectomy

Resource links provided by NLM:


Further study details as provided by Wakayama Medical University:

Primary Outcome Measures:
  • the length of hospital stay after pancreaticoduodenectomy [ Time Frame: the day of discharge ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • early and late complications after pancreaticoduodenectomy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: April 2005
Study Completion Date: February 2008
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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)

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00628186

Locations
Japan
Wakayama Medical University , Second Department of Surgery
811-1 Kimiidera, Wakayama, Wakayama, Japan, 641-8510
Sponsors and Collaborators
Wakayama Medical University
Investigators
Study Director: Masaji Tani, MD Wakayama Medical University, Second Department of Surgery
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Second Department of Surgery, Wakayama Medical University
ClinicalTrials.gov Identifier: NCT00628186     History of Changes
Other Study ID Numbers: WP-0501
Study First Received: January 23, 2008
Last Updated: January 15, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Wakayama Medical University:
pancreaticoduodenectomy
stent
pancreaticojejunostomy
hospital stay
complication
pancreatic fistula

Additional relevant MeSH terms:
Pancreatic Neoplasms
Pancreatitis
Duodenal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Duodenal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 22, 2014