External Pancreatic Duct Stent After Pancreaticoduodenectomy

Phase 3

Completed

• Conditions: Pancreatic Fistula
• Interventions: Procedure: External pancreatic stent

• Registration Number: NCT01068886
• Lead Sponsor: University Hospital, Angers

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).

Study Timeline

• Study First Submitted: 2005-09-14
• Study Start: 2006-01
• Primary Completion: 2009-04
• Study Completion: 2009-12
• Status Verified: 2010-02
• Study First Submitted QC: 2010-02-12
• Last Update Submitted: 2010-02-12
• Study First Posted: 2010-02-15
• Last Update Posted: 2010-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stent	External pancreatic stent	stent through pancreatic anastomosis

Primary Outcome Measures

Name	Time	Method
pancreatic fistula	on postoperative day 30

Secondary Outcome Measures

Name	Time	Method
overall morbidity	postoperative day 30

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Angers, France