Clinical trial NCT00679952: Closed Suction Drainage and Natural Drainage of the Pancreatic Duct in Pancreaticojejunostomy
Official title: Randomised Prospective Study of Clinical Outcomes After Closed Suction Drainage and Natural Drainage of the Pancreatic Duct in Pancreaticojejunostomy After Pancreatoduodenectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Fistula
Keywords: Pancreatic fistula
Pancreatic duct stent
Closed suction drainage
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2008-05-19
Enrollment: 168
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients With Pancreatic Fistula
timeFrame: postoperative 1 week
Secondary outcomes:
measure: Severity of Pancreatic Fistulas
timeFrame: 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Sun-Whe Kim, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hamanaka Y, Suzuki T. Total pancreatic duct drainage for leakproof pancreatojejunostomy. Surgery. 1994 Jan;115(1):22-6.
citation: Mok KT, Wang BW, Liu SI. Management of pancreatic remnant with strategies according to the size of pancreatic duct after pancreaticoduodenectomy. Br J Surg. 1999 Aug;86(8):1018-9. doi: 10.1046/j.1365-2168.1999.01206.x. No abstract available.
citation: Poon RT, Fan ST, Lo CM, Ng KK, Yuen WK, Yeung C, Wong J. External drainage of pancreatic duct with a stent to reduce leakage rate of pancreaticojejunostomy after pancreaticoduodenectomy: a prospective randomized trial. Ann Surg. 2007 Sep;246(3):425-33; discussion 433-5. doi: 10.1097/SLA.0b013e3181492c28.
citation: Lee SE, Yang SH, Jang JY, Kim SW. Pancreatic fistula after pancreaticoduodenectomy: a comparison between the two pancreaticojejunostomy methods for approximating the pancreatic parenchyma to the jejunal seromuscular layer: interrupted vs continuous stitches. World J Gastroenterol. 2007 Oct 28;13(40):5351-6. doi: 10.3748/wjg.v13.i40.5351.