Clinical trial NCT00931554: Randomized Trial of Early Versus Standard Drainage Removal After Pancreatic Resections
Official title: Early Versus Standard Drainage Removal After Pancreatic Resections: Results of a Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreaticoduodenectomy
Distal Pancreatectomy
Pancreatic Fistula
Abdominal Abscess
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2009-07-02
Enrollment: 114
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Abdominal Complications
timeFrame: 1 month
Secondary outcomes:
measure: In-hospital stay
timeFrame: 1 month
measure: Pulmonary complications
timeFrame: 1 month
measure: Hospital readmission
timeFrame: 1 month
Other outcomes:
Locations:
city: Verona
country: Italy
facility: General Surgery B, Policlinico G.B. Rossi
Study officials:
References:
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. doi: 10.1097/SLA.0b013e3180caa42f.
citation: 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.
citation: 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.