NCT01068886

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2006

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2005

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 15, 2010

Completed
Last Updated

February 15, 2010

Status Verified

February 1, 2010

Enrollment Period

3.2 years

First QC Date

September 14, 2005

Last Update Submit

February 12, 2010

Conditions

Pancreatic Fistula

Keywords

Pancreaticoduodenectomy

Outcome Measures

Primary Outcomes (1)

  • pancreatic fistula

    on postoperative day 30

Secondary Outcomes (1)

  • overall morbidity

    postoperative day 30

Study Arms (2)

no stent

NO INTERVENTION

no stent through pancreatic anastomosis

stent

EXPERIMENTAL

stent through pancreatic anastomosis

Procedure: External pancreatic stent

Interventions

External pancreatic stentPROCEDURE

stent through pancreatic anastomosis

Also known as: pancreatic stent
stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients scheduled for elective PD,
  • Confirmation of the soft pancreas or nondilated pancreatic duct during PD.

You may not qualify if:

  • Age less than 18 year,
  • Emergency surgery,
  • Previous pancreatic surgery,
  • Previous susmesocolic radiotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Angers, 49933, France

Location

Related Publications (1)

  • Pessaux P, Sauvanet A, Mariette C, Paye F, Muscari F, Cunha AS, Sastre B, Arnaud JP; Federation de Recherche en Chirurgie (French). External pancreatic duct stent decreases pancreatic fistula rate after pancreaticoduodenectomy: prospective multicenter randomized trial. Ann Surg. 2011 May;253(5):879-85. doi: 10.1097/SLA.0b013e31821219af.

    PMID: 21368658DERIVED

MeSH Terms

Conditions

Pancreatic Fistula

Condition Hierarchy (Ancestors)

Digestive System FistulaDigestive System DiseasesPancreatic DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • arnaud - jean-pierre, professor

    University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 14, 2005

First Posted

February 15, 2010

Study Start

January 1, 2006

Primary Completion

April 1, 2009

Study Completion

December 1, 2009

Last Updated

February 15, 2010

Record last verified: 2010-02

Locations

FR(1)