External Pancreatic Duct Stent After Pancreaticoduodenectomy

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT01068886
First received: September 14, 2005
Last updated: February 12, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Pancreatic Fistula
Procedure: External pancreatic stent
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: External Pancreatic Duct Stent After Pancreaticoduodenectomy: a Prospective Randomized Multicenter Trial

Resource links provided by NLM:


Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:
  • pancreatic fistula [ Time Frame: on postoperative day 30 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • overall morbidity [ Time Frame: postoperative day 30 ] [ Designated as safety issue: Yes ]

Enrollment: 150
Study Start Date: January 2006
Study Completion Date: December 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: no stent
no stent through pancreatic anastomosis
Experimental: stent
stent through pancreatic anastomosis
Procedure: External pancreatic stent
stent through pancreatic anastomosis
Other Name: pancreatic stent

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01068886

Locations
France
University Hospital
Angers, France, 49933
Sponsors and Collaborators
University Hospital, Angers
Investigators
Principal Investigator: arnaud - jean-pierre, professor University Hospital
  More Information

No publications provided by University Hospital, Angers

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yvonnick MORICE, Centre Hospitalier Universitaire
ClinicalTrials.gov Identifier: NCT01068886     History of Changes
Other Study ID Numbers: PHRC 04-04
Study First Received: September 14, 2005
Last Updated: February 12, 2010
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Angers:
Pancreaticoduodenectomy

Additional relevant MeSH terms:
Pancreatic Fistula
Digestive System Fistula
Digestive System Diseases
Pancreatic Diseases
Fistula
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 30, 2014