Comparison of Feasibility Between Internal and External Pancreatic Drainage in Pancreaticoduodenectomy

Pancreatic Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01023594
• Other study ID #: H-0908-040-290
• Status: Active, not recruiting
• Phase: N/A
• First received: November 30, 2009
• Last updated: September 14, 2015
• Start date: January 2010
• Est. completion date: January 2016

Study information

• Verified date: September 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 328
• Est. completion date: January 2016
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pancreatic Fistula

Intervention

Procedure:
• Pancreatic stent
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.

Locations

Country	Name	City	State
Korea, Republic of	Center for Liver Cancer, National Cancer Center	Goyang-si	Gyeonggi-do
Korea, Republic of	Department of Surgery, Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do
Korea, Republic of	Department of Surgery, Chung-ang University College of Medicine	Seoul
Korea, Republic of	Department of Surgery, Gangnam Severance Hospital	Seoul
Korea, Republic of	Department of Surgery, Korea University Guro Hospital	Seoul
Korea, Republic of	Department of Surgery, Samsung Medical Center	Seoul
Korea, Republic of	Department of Surgery, Seoul National University Boramae Hospital	Seoul
Korea, Republic of	Department of Surgery, Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (10)

Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. Review. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Lowy AM, Lee JE, Pisters PW, Davidson BS, Fenoglio CJ, Stanford P, Jinnah R, Evans DB. Prospective, randomized trial of octreotide to prevent pancreatic fistula after pancreaticoduodenectomy for malignant disease. Ann Surg. 1997 Nov;226(5):632-41. Review. — View 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. — View 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. — View Citation

Roder JD, Stein HJ, Böttcher KA, Busch R, Heidecke CD, Siewert JR. Stented versus nonstented pancreaticojejunostomy after pancreatoduodenectomy: a prospective study. Ann Surg. 1999 Jan;229(1):41-8. — View Citation

Winter JM, Cameron JL, Campbell KA, Chang DC, Riall TS, Schulick RD, Choti MA, Coleman J, Hodgin MB, Sauter PK, Sonnenday CJ, Wolfgang CL, Marohn MR, Yeo CJ. Does pancreatic duct stenting decrease the rate of pancreatic fistula following pancreaticoduodenectomy? Results of a prospective randomized trial. J Gastrointest Surg. 2006 Nov;10(9):1280-90; discussion 1290. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evidence of pancreatic fistula confirmed by serum and drain amylase		within the first 7 days after surgery	Yes
Secondary	pancreatic endocrine and exocrine function by blood test, stool exam (steatorrhea) and computed tomography (CT) volumetry		within the first 1 year after surgery	No