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

• ClinicalTrials.gov Identifier: NCT00679952
• Recruitment Status: Completed
• First Posted: May 19, 2008
• Results First Posted: May 9, 2011
• Last Update Posted: May 19, 2014
• Sponsor: Seoul National University Hospital
• Information provided by (Responsible Party): Seoul National University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pancreatic Fistula	Procedure: closed suction drainage of pancreatic duct; Procedure: natural drainage of pancreatic duct	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 168 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Randomised Prospective Study of Clinical Outcomes After Closed Suction Drainage and Natural Drainage of the Pancreatic Duct in Pancreaticojejunostomy After Pancreatoduodenectomy
• Study Start Date: March 2007
• Actual Primary Completion Date: March 2009
• Actual Study Completion Date: March 2010

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1; closed suction drainage group (CD group)	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
Active Comparator: 2; natural drainage group (ND group)	Procedure: natural drainage of pancreatic duct; Natural drainage group; Other Name: pancreaticojejunostomy

Outcome Measures

Primary Outcome Measures :

1. Number of Patients With Pancreatic Fistula [ Time Frame: postoperative 1 week ]

   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

Secondary Outcome Measures :

1. Severity of Pancreatic Fistulas [ Time Frame: 2 years ]

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 85 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Korea, Republic of

Seoul National University Hospital

Seoul, Korea, Republic of, 110-744

Sponsors and Collaborators

Seoul National University Hospital

Investigators

• Principal Investigator: Sun-Whe Kim, MD., PhD.; Seoul National University Hospital

More Information

Publications:

Hamanaka Y, Suzuki T. Total pancreatic duct drainage for leakproof pancreatojejunostomy. Surgery. 1994 Jan;115(1):22-6.

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.

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.

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.

• Responsible Party: Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT00679952
• Other Study ID Numbers: H-0612-018-191
• First Posted: May 19, 2008
• Results First Posted: May 9, 2011
• Last Update Posted: May 19, 2014
• Last Verified: May 2014

Keywords provided by Seoul National University Hospital:

Pancreatic fistula; Pancreatic duct stent; Closed suction drainage

Additional relevant MeSH terms:

Pancreatic Fistula; Fistula; Pathological Conditions, Anatomical; Digestive System Fistula; Digestive System Diseases; Pancreatic Diseases