Early (4 Days) Versus Standard Drainage of the Abdominal Cavity After Pancreaticoduodenectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Centre Hospitalier Universitaire, Amiens.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT01368094
First received: June 6, 2011
Last updated: December 19, 2011
Last verified: December 2011
  Purpose

Around two thousand pancreaticoduodenectomy (PD) are performed each year in France. This intervention is associated with a high rate of postoperative complications including:

  • pancreatic fistulas (PF);
  • surgical site infections (intra-abdominal abscess, wound infection);
  • delayed gastric emptying (gastroparesis);
  • and hemorrhage.

The incidence of SSI (superficial and deep) is about 35% and seems influenced by the prolonged intra-abdominal drainage. For several years, there has been a global trend to reduce the use of abdominal drainage after abdominal surgery. Several randomized clinical trials have shown that prophylactic drainage does not decrease the incidence of postoperative complications during elective hepatectomy, colectomy, and cholecystectomy and could increase the number of SSI. However, the role of prophylactic drainage after PD is so far unclear.

The aim of this prospective randomized multicenter study is to evaluate the influence of early (4 days) versus standard (10 to 15 days, depending on the staff clinical practice) drainage removal of the abdominal cavity after PD, on the rate of SSI.

Materials and Methods: The technique of PD is left at the discretion of the operator as well as the prescription of analogues of somatostatin. Drainage of the abdominal cavity is made of one or two round silicone close suction drains or open multichannel silicone drains placed in the vicinity of the pancreatic and biliary anastomosis. Shall be excluded patients operated on for chronic pancreatitis and patients who underwent preoperative radiotherapy. The 3rd postoperative day, a fistula is sought clinically, biologically and on CT-scanner images. In case of pancreatic fistula, the patient is excluded from randomization and drainage of the abdominal cavity is left in place depending on the different teams' practice. Patients without fistula are randomized to either drainage removal 4 days after surgery (D4) or standard drainage.


Condition Intervention
Pancreatic Disease
Pancreatic Neoplasms
Procedure: Drain removal at D4
Procedure: Standard drain removal

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Early (4 Days) Versus Standard Drainage Removal of the Abdominal Cavity After Pancreaticoduodenectomy- - A Randomized Multicenter Study

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire, Amiens:

Primary Outcome Measures:
  • Surgical Site Infection at D30 [ Time Frame: 30 days after surgical intervention ] [ Designated as safety issue: No ]

    The outcome measure is the occurrence of surgical site infection (SSI) at D30, as defined by:

    • surface SSI (wound abscess): infection of the skin, subcutaneous tissue or muscle, above the fascia, located at a surgical incision.
    • deep SSI (intra-abdominal abscess) infection in operated tissues or in site of intervention (under the fascia).


Estimated Enrollment: 138
Study Start Date: June 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard drainage Procedure: Standard drain removal
If no pancreatic fistula (PF) or deep SSI is highlighted on the CT-scanner on day 3 postoperatively, the drain will be removed following the clinical routine practice of the surgical team that takes the patient in charge. The patient will leave the department when the surgeon deems necessary.
Experimental: Short drainage Procedure: Drain removal at D4
If no pancreatic fistula (PF) or deep SSI is highlighted neither on the CT-scanner nor with biological analysis, on day 3 postoperatively, the drain will be removed on the 4th postoperative day, at the patient's bedside.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pancreatic tumor regardless of its nature: All patients requiring PD (following thesaurus or multidisciplinary team council recommendation) for this indication will be included.
  • Ability to participate in a clinical research protocol.
  • Given informed consent.

Exclusion Criteria:

  • History of pancreatic surgery or biliary diversion and / or digestive
  • Patient taken in charge for chronic pancreatitis without tumor
  • History of supramesocolic radiotherapy
  • Sick supported emergency
  • Physical or mental condition does not allow participation in the study
  • Contra-indication to surgery
  • ASA classification (American Society of Anesthesiologists) IV-V or life expectancy <48
  • Pregnancy or breastfeeding
  • Patient under guardianship or private patient of liberty by a judicial or administrative decision
  • Age under 18yo
  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: NCT01368094

Contacts
Contact: Jean-Marc REGIMBEAU, Pr +333 22 66 83 00 regimbeau.jean-marc@chu-amiens.fr

Locations
France
CHU Amiens Recruiting
Amiens, Picardie, France, 80000
Contact: Jean-Marc REGIMBEAU, Md-PHD         
Principal Investigator: Jean-Marc REGIMBEAU, MD-PhD         
Centre Hospitalier de Beauvais Not yet recruiting
Beauvais, France, 60000
Contact: François MAUVAIS, Md    +333 44 11 21 21    f.mauvais@ch-beauvais.fr   
Centre Hospitalier Saint-Martin Not yet recruiting
Caen, France, 14050
Contact: Laurence CHICHE, Pr    +332 31 06 50 20    chiche-l@chu-caen.fr   
Centre Hospitalier Régional Universitaire Claude Huriez Recruiting
Lille, France, 59037
Contact: Christophe MARIETTE, Pr    +333 20 44 44 07    c-mariette@chru-lille.fr   
Contact: François-René PRUVOT, Pr    +333 20 44 42 60    francois-rene.pruvot@chru-lille.fr   
Centre Hospitalier Charles Nicolle Not yet recruiting
Rouen, France, 76 031
Contact: Michel SCOTTE, Pr    +332 32 88 01 26    michel.scotte@chu-rouen.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Principal Investigator: Jean-Marc REGIMBEAU, Pr Centre Hospitalier Régional Universitaire d'Amiens
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01368094     History of Changes
Other Study ID Numbers: PHRCIR10-PR-REGIMBEAU, 2010-A01347-32
Study First Received: June 6, 2011
Last Updated: December 19, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire, Amiens:
Pancreaticoduodenectomy
Drainage
Surgical site infection

Additional relevant MeSH terms:
Pancreatic Neoplasms
Pancreatic Diseases
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 01, 2014