Early (4 Days) Versus Standard Drainage of the Abdominal Cavity After Pancreaticoduodenectomy
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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 |
- 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 |
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| Contact: Jean-Marc REGIMBEAU, Pr | +333 22 66 83 00 | regimbeau.jean-marc@chu-amiens.fr |
| 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 | |
| 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:
|
Neoplasms Pancreatic Diseases Pancreatic Neoplasms Digestive System Diseases |
Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013