Clinical trial · Interventional
Early (4 Days) Versus Standard Drainage of the Abdominal Cavity After Pancreaticoduodenectomy
Early (4 Days) Versus Standard Drainage Removal of the Abdominal Cavity After Pancreaticoduodenectomy- - A Randomized Multicenter Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Disease | — | UNRESOLVED | — |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drain removal at D4 | Procedure | — | UNRESOLVED |
| Standard drain removal | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard drainage
- interventionNames
- Procedure: Standard drain removal
- type
- EXPERIMENTAL
- label
- Short drainage
- interventionNames
- Procedure: Drain removal at D4
Primary outcomes (1)
- measure
- Surgical Site Infection at D30
- timeFrame
- 30 days after surgical intervention
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTDembinski 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