Randomized Trial of Early Versus Standard Drainage Removal After Pancreatic Resections

University of Verona

Status: Completed

Conditions: Pancreatic Fistula; Distal Pancreatectomy; Abdominal Abscess; Pancreaticoduodenectomy

Treatments: Procedure: Postoperative drain removal

Study type: Interventional

Funder types: Other

Identifiers

NCT00931554

DREN-01

Details and patient eligibility

About

Despite a substantial decrease in postoperative mortality, morbidity after pancreatic resections is still high, even at high-volume centers. It has been recently suggested that early removal of postoperative drainages is associated to a decreased rate of intra-abdominal complications, with particular regard to pancreatic fistula. Furthermore, our research group demonstrated that measuring amylase value in drainages (AVD) on postoperative day 1 plays a cardinal role in predicting the developement of abdominal complications, including pancreatic fistula. In particular, patients with an AVD lower than 5000 IU/L in postoperative day 1 were considered at low risk of fistula. Therefore, the investigators designed a randomized prospective trial on early (postoperative day 3) versus standard (postoperative day 5) drainages removal after pancreatic resections in patients at low risk of developing pancreatic fistula (AVD < 5000 IU/L in postoperative day 1) to test whether drainages "per se" influence postoperative complication rates and to eventually validate a fast-track policy in pancreatic resections.

Enrollment: 114 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergone either pancreaticoduodenectomy (reconstruction by pancreaticojejunostomy) or distal pancreatectomy with an amylase value in drains on postoperative day 1 less than 5000 IU/L

Exclusion criteria

• Pancreaticoduodenectomy reconstructed with pancreaticogastrostomy
• Clinical suspect of postoperative haemorrhage within 72hours after the operation
• Clinical suspect of biliary fistula
• Fluid collection greater than 3cm at an ultrasound carried out on postoperative day 3

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

Early drain removal

Active Comparator group

Description:

Drain removal in postoperative day 3

Treatment:

Procedure: Postoperative drain removal

Standard drain removal

Active Comparator group

Description:

Drain removal on postoperative day 5

Treatment:

Procedure: Postoperative drain removal