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

Primary Purpose

Pancreatic Fistula

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
closed suction drainage of pancreatic duct
natural drainage of pancreatic duct
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pancreatic Fistula focused on measuring Pancreatic fistula, Pancreatic duct stent, Closed suction drainage

Eligibility Criteria

15 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

closed suction drainage group (CD group)

natural drainage group (ND group)

Outcomes

Primary Outcome Measures

Number of Patients With Pancreatic Fistula
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

Severity of Pancreatic Fistulas

Full Information

First Posted
May 15, 2008
Last Updated
May 8, 2014
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00679952
Brief Title
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

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Fistula
Keywords
Pancreatic fistula, Pancreatic duct stent, Closed suction drainage

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
closed suction drainage group (CD group)
Arm Title
2
Arm Type
Active Comparator
Arm Description
natural drainage group (ND group)
Intervention Type
Procedure
Intervention Name(s)
closed suction drainage of pancreatic duct
Other Intervention Name(s)
pancreaticojejunostomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
natural drainage of pancreatic duct
Other Intervention Name(s)
pancreaticojejunostomy
Intervention Description
Natural drainage group
Primary Outcome Measure Information:
Title
Number of Patients With Pancreatic Fistula
Description
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
Time Frame
postoperative 1 week
Secondary Outcome Measure Information:
Title
Severity of Pancreatic Fistulas
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun-Whe Kim, MD., PhD.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
8284756
Citation
Hamanaka Y, Suzuki T. Total pancreatic duct drainage for leakproof pancreatojejunostomy. Surgery. 1994 Jan;115(1):22-6.
Results Reference
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PubMed Identifier
10460636
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.
Results Reference
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PubMed Identifier
17717446
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.
Results Reference
background
PubMed Identifier
17879405
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.
Results Reference
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Closed Suction Drainage and Natural Drainage of the Pancreatic Duct in Pancreaticojejunostomy

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