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External Pancreatic Duct Stent After Pancreaticoduodenectomy

NCT01068886 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2010-02-15

No results posted yet for this study

Summary

Pancreatoduodenectomy (PD) is performed in many high volume centers with a very low mortality. Reduced mortality rate is largely the result of careful patient selection, improved intraoperative management and a better postoperative care. Unfortunately, there is not a similar reduction in morbidity rates which remains about 40%. Persistent morbidity is predominantly due to pancreatic fistula (PF). Abdominal abscess and hemorrhage are common sequelae of PF which have been associated with a high mortality rate. While many different risk factors have been reported, a soft pancreatic texture and a nondilated pancreatic duct have been most consistently linked to high rates of PF. A number of methods for reducing the incidence of PF have been proposed and analysed. Many of these involve technical features of the anastomosis, including site of reconstruction, anastomotic technique, use of biologic glue, and prophylactic use of somatostatin analogue. The placement of a stent through the pancreatic anastomosis is an attractive strategy to reduce the PF rate. This multicenter prospective randomized trial was designed to compare the outcome after PD with external drainage stent versus no stent in patients with high risk of PF (with soft pancreas and a diameter of wirsung \<3mm).

Analysis:The primary objective of the study was to compare the incidence PF in patients with or without external pancreatic stent. With an anticipated PF rate of 30%, based on literature experience, it was calculated that a reduction to 10% of PF rate would require the inclusion of 75 patients in each group (statistical significance P \< 0.05 and power 80 per cent with a two-tailed test of proportions). We'll enroll 158 patients to take into account the possibility of 5% being lost to follow-up.

Conditions

  • Pancreatic Fistula

Interventions

PROCEDURE

External pancreatic stent

stent through pancreatic anastomosis

Sponsors & Collaborators

  • University Hospital, Angers

    lead OTHER_GOV

Principal Investigators

  • arnaud - jean-pierre, professor · University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2009-04-30
Completion
2009-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01068886 on ClinicalTrials.gov