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CompletedNCT00931554Updated Jul 2, 2009

Randomized Trial of Early Versus Standard Drainage Removal After Pancreatic Resections

An interventional study of Postoperative drain removal in Pancreaticoduodenectomy, Distal Pancreatectomy and Pancreatic Fistula, sponsored by Universita di Verona. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2009-07-02.

Sponsored by Universita di Verona · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
114
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Pancreaticoduodenectomy
  • Distal Pancreatectomy
  • Pancreatic Fistula
  • Abdominal Abscess
03

In context

Pancreatic Fistula

122 studies on the registry are indexed under Pancreatic Fistula; 27 are open to participants now.

This study's enrollment of 114 is close to the median of 110 across 77 interventional studies indexed under Pancreatic Fistula.

Browse Pancreatic Fistula studies →

Lead sponsor

Universita di Verona is the lead sponsor of 125 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
114 participants (actual)

Study arms

  • Active comparator
    Early drain removal

    Drain removal in postoperative day 3

    Procedure: Postoperative drain removal

  • Active comparator
    Standard drain removal

    Drain removal on postoperative day 5

    Procedure: Postoperative drain removal

Interventions

  • ProcedurePostoperative drain removal

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

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What researchers measure

Primary outcomes

  1. Abdominal Complications

    Time frame: 1 month

Secondary outcomes

  1. In-hospital stay

    Time frame: 1 month

  2. Pulmonary complications

    Time frame: 1 month

  3. Hospital readmission

    Time frame: 1 month

07

Study locations

1 site
  • General Surgery B, Policlinico G.B. Rossi
    Verona, 37134, Italy
08

References and documents

Publications

  • Molinari E, Bassi C, Salvia R, Butturini G, Crippa S, Talamini G, Falconi M, Pederzoli P. Amylase value in drains after pancreatic resection as predictive factor of postoperative pancreatic fistula: results of a prospective study in 137 patients. Ann Surg. 2007 Aug;246(2):281-7. doi: 10.1097/SLA.0b013e3180caa42f. PubMed 17667507 ↗
  • Kawai M, Tani M, Terasawa H, Ina S, Hirono S, Nishioka R, Miyazawa M, Uchiyama K, Yamaue H. Early removal of prophylactic drains reduces the risk of intra-abdominal infections in patients with pancreatic head resection: prospective study for 104 consecutive patients. Ann Surg. 2006 Jul;244(1):1-7. doi: 10.1097/01.sla.0000218077.14035.a6. PubMed 16794381 ↗
  • Bassi C, Molinari E, Malleo G, Crippa S, Butturini G, Salvia R, Talamini G, Pederzoli P. Early versus late drain removal after standard pancreatic resections: results of a prospective randomized trial. Ann Surg. 2010 Aug;252(2):207-14. doi: 10.1097/SLA.0b013e3181e61e88. PubMed 20622661 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00931554
First posted
Jul 2, 2009
Start date
Mar 2007
Completion
Apr 2008
Last update
Jul 2, 2009

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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