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Comparison of Feasibility Between Internal and External Pancreatic Drainage in Pancreaticoduodenectomy

Primary Purpose

Pancreatic Fistula

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Pancreatic stent

About this trial

This is an interventional prevention trial for Pancreatic Fistula focused on measuring Pancreatic fistula, Pancreatic leakage, Pancreatoduodenectomy, Pancreatic stent

Eligibility Criteria

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

Inclusion Criteria:

patient who have malignant or benign disease which needs pancreatoduodenectomy
patient age: ≥20 and ≤85

Exclusion Criteria:

patient who had chemotherapy or radiotherapy previous to operation.
patient who had severe comorbid disease(cardiac, pulmonary, cerebrovascular)
patient who had past medical history of chronic pancreatitis.
pancreatic stent size <1mm or >5mm

Sites / Locations

Center for Liver Cancer, National Cancer Center
Department of Surgery, Seoul National University Bundang Hospital
Department of Surgery, Seoul National University Hospital
Department of Surgery, Samsung Medical Center
Department of Surgery, Korea University Guro Hospital
Department of Surgery, Seoul National University Boramae Hospital
Department of Surgery, Chung-ang University College of Medicine
Department of Surgery, Gangnam Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

External stent

Internal stent

Arm Description

Feeding tube insert at pancreatojejunostomy site as a stent. And stent tube is brought out through jejunal loop below the hepaticojejunostomy site and abdominal wall.

short(5cm)internal stent insertion at pancreatojejunostomy site

Outcomes

Primary Outcome Measures

evidence of pancreatic fistula confirmed by serum and drain amylase

Secondary Outcome Measures

pancreatic endocrine and exocrine function by blood test, stool exam (steatorrhea) and computed tomography (CT) volumetry

Full Information

NCT ID

NCT01023594

First Posted

November 30, 2009

Last Updated

September 14, 2015

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01023594

Brief Title

Comparison of Feasibility Between Internal and External Pancreatic Drainage in Pancreaticoduodenectomy

Official Title

Comparison of Feasibility Between Internal and External Pancreatic Drainage in Pancreaticoduodenectomy: Prospective Randomized Study

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Unknown status

Study Start Date

January 2010 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Pancreatic fistula is one of the most serious complication after pancreatoduodenectomy. To reduce pancreatic fistula, many authors recommend pancreatic stent in pancreatojejunostomy. There are two distinct methods of pancreatic stent insertion: internal stent and external stent. There was few studies comparing these methods in preventing pancreatic fistula. Furthermore, its long-term effect was not known enough. The purpose of this study is to determine which is the best method in preventing pancreatic fistula and to investigate its long term clinical outcomes.

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 leakage, Pancreatoduodenectomy, Pancreatic stent

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

328 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

External stent

Arm Type

Active Comparator

Arm Description

Feeding tube insert at pancreatojejunostomy site as a stent. And stent tube is brought out through jejunal loop below the hepaticojejunostomy site and abdominal wall.

Arm Title

Internal stent

Arm Type

Active Comparator

Arm Description

short(5cm)internal stent insertion at pancreatojejunostomy site

Intervention Type

Procedure

Intervention Name(s)

Pancreatic stent

Intervention Description

Feeding tube insert at pancreatojejunostomy site as a stent. And then 1) tube is brought out through jejunal loop below the hepaticojejunostomy site and abdominal wall(external stent)or 2) tube is cut short (5cm length) and left in situ with fixating suture. In external stent group, tube will be removed about 1 months after operation.

Primary Outcome Measure Information:

Title

evidence of pancreatic fistula confirmed by serum and drain amylase

Time Frame

within the first 7 days after surgery

Secondary Outcome Measure Information:

Title

pancreatic endocrine and exocrine function by blood test, stool exam (steatorrhea) and computed tomography (CT) volumetry

Time Frame

within the first 1 year after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patient who have malignant or benign disease which needs pancreatoduodenectomy patient age: ≥20 and ≤85 Exclusion Criteria: patient who had chemotherapy or radiotherapy previous to operation. patient who had severe comorbid disease(cardiac, pulmonary, cerebrovascular) patient who had past medical history of chronic pancreatitis. pancreatic stent size <1mm or >5mm

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sun-Whe Kim, M.D.

Organizational Affiliation

Seoul National University Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Center for Liver Cancer, National Cancer Center

City

Goyang-si

State/Province

Gyeonggi-do

ZIP/Postal Code

410-769

Country

Korea, Republic of

Facility Name

Department of Surgery, Seoul National University Bundang Hospital

City

Seongnam

State/Province

Gyeonggi-do

ZIP/Postal Code

463-707

Country

Korea, Republic of

Facility Name

Department of Surgery, Seoul National University Hospital

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Name

Department of Surgery, Samsung Medical Center

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

Department of Surgery, Korea University Guro Hospital

City

Seoul

ZIP/Postal Code

152-703

Country

Korea, Republic of

Facility Name

Department of Surgery, Seoul National University Boramae Hospital

City

Seoul

ZIP/Postal Code

156-707

Country

Korea, Republic of

Facility Name

Department of Surgery, Chung-ang University College of Medicine

City

Seoul

Country

Korea, Republic of

Facility Name

Department of Surgery, Gangnam Severance Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

16003309

Citation

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Results Reference

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PubMed Identifier

9389397

Citation

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Results Reference

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PubMed Identifier

18535760

Citation

Butturini G, Daskalaki D, Molinari E, Scopelliti F, Casarotto A, Bassi C. Pancreatic fistula: definition and current problems. J Hepatobiliary Pancreat Surg. 2008;15(3):247-51. doi: 10.1007/s00534-007-1301-y. Epub 2008 Jun 6.

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

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PubMed Identifier

9923798

Citation

Roder JD, Stein HJ, Bottcher KA, Busch R, Heidecke CD, Siewert JR. Stented versus nonstented pancreaticojejunostomy after pancreatoduodenectomy: a prospective study. Ann Surg. 1999 Jan;229(1):41-8. doi: 10.1097/00000658-199901000-00005.

Results Reference

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PubMed Identifier

18516532

Citation

Kamoda Y, Fujino Y, Matsumoto I, Shinzeki M, Sakai T, Kuroda Y. Usefulness of performing a pancreaticojejunostomy with an internal stent after a pancreatoduodenectomy. Surg Today. 2008;38(6):524-8. doi: 10.1007/s00595-007-3662-x. Epub 2008 May 31.

Results Reference

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PubMed Identifier

12413321

Citation

Ohwada S, Tanahashi Y, Ogawa T, Kawate S, Hamada K, Tago KI, Yamada T, Morishita Y. In situ vs ex situ pancreatic duct stents of duct-to-mucosa pancreaticojejunostomy after pancreaticoduodenectomy with billroth I-type reconstruction. Arch Surg. 2002 Nov;137(11):1289-93. doi: 10.1001/archsurg.137.11.1289.

Results Reference

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PubMed Identifier

16708294

Citation

Imaizumi T, Hatori T, Tobita K, Fukuda A, Takasaki K, Makuuchi H. Pancreaticojejunostomy using duct-to-mucosa anastomosis without a stenting tube. J Hepatobiliary Pancreat Surg. 2006;13(3):194-201. doi: 10.1007/s00534-005-1037-5.

Results Reference

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PubMed Identifier

9230663

Citation

Kim SW, Youk EG, Park YH. Comparison of pancreatogastrostomy and pancreatojejunostomy after pancreatoduodenectomy performed by one surgeon. World J Surg. 1997 Jul-Aug;21(6):640-3. doi: 10.1007/s002689900286.

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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Results Reference

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Comparison of Feasibility Between Internal and External Pancreatic Drainage in Pancreaticoduodenectomy

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