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Closed Suction Drainage and Natural Drainage of the Pancreatic Duct in Pancreaticojejunostomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00679952
First received: May 15, 2008
Last updated: May 8, 2014
Last verified: May 2014

May 15, 2008
May 8, 2014
March 2007
March 2009   (final data collection date for primary outcome measure)
Number of Patients With Pancreatic Fistula [ Time Frame: postoperative 1 week ] [ Designated as safety issue: Yes ]

pancreatic fistula rate is stratified according to ISGPF criteria.

Grade A; No major impact Grade B; Clinically relevant fistula, specific treatment may be required Grade C; Most severe form of fistula, with a high mortality rate

pancreatic fistula rates [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00679952 on ClinicalTrials.gov Archive Site
Severity of Pancreatic Fistulas [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Closed Suction Drainage and Natural Drainage of the Pancreatic Duct in Pancreaticojejunostomy
Randomised Prospective Study of Clinical Outcomes After Closed Suction Drainage and Natural Drainage of the Pancreatic Duct in Pancreaticojejunostomy After Pancreatoduodenectomy

Pancreaticojejunal anastomosis leakage is a major complication after pancreatoduodenectomy and various technical methods have been examined to improve the situation.However, none of methods have been successful at improving results according to the findings of prospective randomized studies. We propose that active drainage of pancreatic juice using suction drainage might maximize the advantage of a stent and finally reduce pancreaticojejunal anastomosis leakage.

Pancreaticojejunal anastomosis leakage is a major complication after pancreatoduodenectomy and various technical methods have been examined to improve the situation, e.g., pancreatic duct occlusion, anastomosis reinforcement with fibrin glue, placement of an internal stent, and pancreaticogastrostomy. However, none of these methods have been successful at improving results according to the findings of prospective randomized studies. Some retrospective studies have reported a low pancreatic fistula rate when a catheter is inserted into the pancreatic duct to externally drain pancreatic juice. Furthermore, a recent prospective randomized trial showed that external drainage of the pancreatic duct decreased the rate of pancreatic fistula formation indicating that diverting pancreatic juice from an anastomosis can theoretically reduce the incidence of pancreaticojejunostomy anastomotic leakage. We propose that active drainage of pancreatic juice using suction drainage might maximize the advantage of a stent and finally reduce pancreaticojejunal anastomosis leakage.

We will enroll all patients who underwent duct-to-mucosa pancreaticojejunostomy reconstruction after pancreatoduodenectomy, and randomly allocate them to two groups of closed suction drainage group (CD group) and natural drainage group (ND group) just after operations.

Preoperative demographic and clinical data, and surgical procedure, pathologic diagnosis, postoperative course and complications details were collected prospectively.

The primary study endpoints were; pancreatic fistula rates, severity of pancreatic fistulas, postoperative complications, postoperative length of hospital stay, and hospital mortality rate. Pancreatic fistula was defined as any measurable drainage from an operatively placed drain (or a subsequently placed percutaneous drain) on or after postoperative day 3, with an amylase content greater than 3 times the upper limit of normal serum amylase level (i.e., >300 IU/L)(International Study Group for Pancreatic Fistulas (ISGPF) definition) or on or after postoperative week 1 drainage of more than 30 mL of fluid with an amylase level higher than 600 U/dL(Seoul National University Hospital (SNUH) definition). In addition, fistula severity was graded as A, B, C according to ISGPF clinical criteria as follows; grade A fistula - a transient, asymptomatic fistula with only elevated drain amylase levels and treatments or deviation in clinical management are not required; grade B fistula - a symptomatic, clinically apparent fistula requiring diagnostic evaluation and therapeutic management; and grade C fistula - a severe, clinically significant fistula requiring a major deviations in clinical management and unequivocal aggressive therapeutic interventions. Major pancreatic leakage was defined as drainage of more than 200 mL of fluid or the development of an intra-abdominal abscess.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Pancreatic Fistula
  • Procedure: closed suction drainage of pancreatic duct
    A Fr 5-8 silastic polyethylene pediatric feeding tube with multiple side-holes is inserted 2 cm into the pancreatic duct. The catheter exited via a small enterotomy in the jejunal loop of the distal portion of the hepaticojejunostomy. Totally externalized pancreatic stents were connected to the aspiration bag of a Jackson-Pratt drain to generate negative pressure or to a bile bag for natural drainage.
    Other Name: pancreaticojejunostomy
  • Procedure: natural drainage of pancreatic duct
    Natural drainage group
    Other Name: pancreaticojejunostomy
  • Active Comparator: 1
    closed suction drainage group (CD group)
    Intervention: Procedure: closed suction drainage of pancreatic duct
  • Active Comparator: 2
    natural drainage group (ND group)
    Intervention: Procedure: natural drainage of pancreatic duct

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
168
March 2010
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients who undergo duct-to-mucosa pancreaticojejunostomy reconstruction after pancreatoduodenectomy in our institution

Exclusion criteria:

  • less than 15 years old, or older than 85 years old
Both
15 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00679952
H-0612-018-191
Yes
Seoul National University Hospital
Seoul National University Hospital
Not Provided
Principal Investigator: Sun-Whe Kim, MD., PhD. Seoul National University Hospital
Seoul National University Hospital
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP