External Pancreatic Duct Stent After Pancreaticoduodenectomy

NCT ID: NCT01068886

Last Updated: 2010-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2009-12-31

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.

Detailed Description

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.

PF was defined, according to the International Study Group of Pancreatic Fistula, as amylase rich fluid (amylase concentration more than three times serum concentration) collected from the drainage placed intraoperatively from day 3 or by needle aspiration of an intraabdominal collection. PF were graded according to the clinical impact on the patient's hospital course (grades A,B,C).

Conditions

Pancreatic Fistula

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

no stent

no stent through pancreatic anastomosis

Group Type: NO_INTERVENTION

No interventions assigned to this group

stent

stent through pancreatic anastomosis

Group Type: EXPERIMENTAL

External pancreatic stent

Intervention Type: PROCEDURE

stent through pancreatic anastomosis

Interventions

External pancreatic stent

stent through pancreatic anastomosis

Intervention Type: PROCEDURE

Other Intervention Names

pancreatic stent

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Centre Hospitalier Universitaire

Principal Investigators

arnaud - jean-pierre, professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital

Locations

University Hospital

Angers, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 21368658 (View on PubMed)

Other Identifiers

PHRC 04-04

Identifier Type: -

Identifier Source: org_study_id