Randomized Trial of Early Versus Standard Drainage Removal After Pancreatic Resections

Pancreatic Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00931554
• Other study ID #: DREN-01
• Status: Completed
• Phase: N/A
• First received: May 28, 2009
• Last updated: July 1, 2009
• Start date: March 2007
• Est. completion date: April 2008

Study information

• Verified date: July 2009
• Source: Universita di Verona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Abdominal Abscess
• Distal Pancreatectomy
• Pancreatic Fistula
• Pancreaticoduodenectomy

Intervention

Procedure:
• Postoperative drain removal
removal of postoperative drainages at different time points (postoperative day 3 versus postoperative day 5)

Locations

Country	Name	City	State
Italy	General Surgery B, Policlinico G.B. Rossi	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal Complications		1 month	No
Secondary	In-hospital stay		1 month	No
Secondary	Pulmonary complications		1 month	No
Secondary	Hospital readmission		1 month	No