NCT00679952

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2007

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 9, 2011

Completed
Last Updated

May 19, 2014

Status Verified

May 1, 2014

Enrollment Period

2 years

First QC Date

May 15, 2008

Results QC Date

March 13, 2011

Last Update Submit

May 8, 2014

Conditions

Pancreatic Fistula

Keywords

Pancreatic fistulaPancreatic duct stentClosed suction drainage

Outcome Measures

Primary Outcomes (1)

  • 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

    postoperative 1 week

Secondary Outcomes (1)

  • Severity of Pancreatic Fistulas

    2 years

Study Arms (2)

1

ACTIVE COMPARATOR

closed suction drainage group (CD group)

Procedure: closed suction drainage of pancreatic duct

2

ACTIVE COMPARATOR

natural drainage group (ND group)

Procedure: natural drainage of pancreatic duct

Interventions

closed suction drainage of pancreatic ductPROCEDURE

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.

Also known as: pancreaticojejunostomy
1
natural drainage of pancreatic ductPROCEDURE

Natural drainage group

Also known as: pancreaticojejunostomy
2

Eligibility Criteria

Age15 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • less than 15 years old, or older than 85 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (4)

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

    PMID: 8284756BACKGROUND

  • 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.

    PMID: 10460636BACKGROUND

  • 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.

    PMID: 17717446BACKGROUND

  • 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.

    PMID: 17879405BACKGROUND

MeSH Terms

Conditions

Pancreatic Fistula

Interventions

Pancreaticojejunostomy

Condition Hierarchy (Ancestors)

Digestive System FistulaDigestive System DiseasesPancreatic DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Results Point of Contact

Title
Clinical instructor
Organization
Seoul National University College of Medicine
meejookang@gmail.com
82-2-2072-2817

Study Officials

  • Sun-Whe Kim, MD., PhD.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2008

First Posted

May 19, 2008

Study Start

March 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2010

Last Updated

May 19, 2014

Results First Posted

May 9, 2011

Record last verified: 2014-05

Locations

KR(1)