Closed Suction Drainage and Natural Drainage of the Pancreatic Duct in Pancreaticojejunostomy
Condition: Pancreatic Fistula
MeSH terms: Pancreatic Fistula; Fistula
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): closed suction drainage of pancreatic duct; natural drainage of pancreatic duct
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; Natural drainage group
Other intervention name(s): pancreaticojejunostomy; pancreaticojejunostomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pancreatic fistula; Pancreatic duct stent; Closed suction drainage