Clinical trial NCT01023594: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Fistula
Keywords: Pancreatic fistula
Pancreatic leakage
Pancreatoduodenectomy
Pancreatic stent
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2009-12-02
Enrollment: 328
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: evidence of pancreatic fistula confirmed by serum and drain amylase
timeFrame: within the first 7 days after surgery
Secondary outcomes:
measure: pancreatic endocrine and exocrine function by blood test, stool exam (steatorrhea) and computed tomography (CT) volumetry
timeFrame: within the first 1 year after surgery
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Center for Liver Cancer, National Cancer Center
state: Gyeonggi-do
city: Seongnam
country: Korea, Republic of
facility: Department of Surgery, Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Department of Surgery, Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Department of Surgery, Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Department of Surgery, Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Department of Surgery, Seoul National University Boramae Hospital
city: Seoul
country: Korea, Republic of
facility: Department of Surgery, Chung-ang University College of Medicine
city: Seoul
country: Korea, Republic of
facility: Department of Surgery, Gangnam Severance Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Sun-Whe Kim, M.D.
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1016/j.surg.2005.05.001.
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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.
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.
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.
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. doi: 10.1016/j.gassur.2006.07.020.
citation: Jang JY, Chang YR, Kim SW, Choi SH, Park SJ, Lee SE, Lim CS, Kang MJ, Lee H, Heo JS. Randomized multicentre trial comparing external and internal pancreatic stenting during pancreaticoduodenectomy. Br J Surg. 2016 May;103(6):668-675. doi: 10.1002/bjs.10160. Epub 2016 Apr 4.