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Randomized Controlled Trial on Pancreatic Stent Tube in Pancreaticoduodenectomy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00628186
Enrollment
100
Registered
2008-03-04
Start date
2005-04-30
Completion date
2008-02-29
Last updated
2010-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

pancreaticoduodenectomy, stent, pancreaticojejunostomy, hospital stay, complication, pancreatic fistula

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.

Interventions

DEVICEexternal 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.

DEVICEinternal 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.

Sponsors

Wakayama Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
the length of hospital stay after pancreaticoduodenectomythe day of discharge

Secondary

MeasureTime frame
early and late complications after pancreaticoduodenectomy6 months

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026