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Randomized Trial of Early Versus Standard Drainage Removal After Pancreatic Resections

Early Versus Standard Drainage Removal After Pancreatic Resections: Results of a Prospective Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00931554
Enrollment
114
Registered
2009-07-02
Start date
2007-03-31
Completion date
2008-04-30
Last updated
2009-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Abscess, Distal Pancreatectomy, Pancreatic Fistula, Pancreaticoduodenectomy

Brief summary

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.

Interventions

PROCEDUREPostoperative drain removal

removal of postoperative drainages at different time points (postoperative day 3 versus postoperative day 5)

Sponsors

Universita di Verona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Abdominal Complications1 month

Secondary

MeasureTime frame
In-hospital stay1 month
Pulmonary complications1 month
Hospital readmission1 month

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026