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

NCT01368094 | Completed

• 2 other identifiers: PHRCIR10-PR-REGIMBEAU2010-A01347-32
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Pancreatic Disease; Pancreatic Neoplasms

Keywords

Pancreaticoduodenectomy; Drainage; Surgical site infection

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infection at D30

  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).

  30 days after surgical intervention

Study Arms (2)

Standard drainage

ACTIVE COMPARATOR

Procedure: Standard drain removal

Short drainage

EXPERIMENTAL

Procedure: Drain removal at D4

Interventions

Drain removal at D4 PROCEDURE

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.

Short drainage

Standard drain removal PROCEDURE

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.

Standard drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (5)

CHU Amiens

Amiens, Picardie, 80000, France

Location

Centre Hospitalier de Beauvais

Beauvais, 60000, France

Location

Centre Hospitalier Saint-Martin

Caen, 14050, France

Location

Centre Hospitalier Régional Universitaire Claude Huriez

Lille, 59037, France

Location

Centre Hospitalier Charles Nicolle

Rouen, 76 031, France

Location

Related Publications (1)

• Dembinski J, Mariette C, Tuech JJ, Mauvais F, Piessen G, Fuks D, Schwarz L, Truant S, Cosse C, Pruvot FR, Regimbeau JM. Early removal of intraperitoneal drainage after pancreatoduodenectomy in patients without postoperative fistula at POD3: Results of a randomized clinical trial. J Visc Surg. 2019 Apr;156(2):103-112. doi: 10.1016/j.jviscsurg.2018.06.006. Epub 2019 Jan 31.

  PMID: 30713100 RESULT

MeSH Terms

Conditions

Pancreatic Diseases; Pancreatic Neoplasms; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Digestive System Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Endocrine System Diseases; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Marc REGIMBEAU, Pr

  Centre Hospitalier Régional Universitaire d'Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2011
• First Posted: June 7, 2011
• Study Start: June 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

FR (5)