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Status unknownNCT01023594Updated Sep 15, 2015

Comparison of Feasibility Between Internal and External Pancreatic Drainage in Pancreaticoduodenectomy

An interventional study of Pancreatic stent in Pancreatic Fistula, sponsored by Seoul National University Hospital. Status unknown at 8 sites in Korea, Republic of. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-09-15.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Sep 2015), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
328
Allocation
Randomized
Ages
20 Years to 85 Years
Sex
All
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Study 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.

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Conditions studied

  • Pancreatic Fistula

Keywords

  • Pancreatic fistula
  • Pancreatic leakage
  • Pancreatoduodenectomy
  • Pancreatic stent
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In context

Pancreatic Fistula

125 studies on the registry are indexed under Pancreatic Fistula; 27 are open to participants now.

This study's planned enrollment of 328 is above the median of 110 across 75 interventional studies indexed under Pancreatic Fistula.

Browse Pancreatic Fistula studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
328 participants (estimated)

Study arms

  • Active comparator
    External stent

    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.

    Procedure: Pancreatic stent

  • Active comparator
    Internal stent

    short(5cm)internal stent insertion at pancreatojejunostomy site

    Procedure: Pancreatic stent

Interventions

  • ProcedurePancreatic 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.

06

What researchers measure

Primary outcomes

  1. evidence of pancreatic fistula confirmed by serum and drain amylase

    Time frame: within the first 7 days after surgery

Secondary outcomes

  1. 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

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Study locations

8 sites
  • Center for Liver Cancer, National Cancer Center
    Goyang-si, Gyeonggi-do 410-769, Korea, Republic of
  • Department of Surgery, Seoul National University Bundang Hospital
    Seongnam, Gyeonggi-do 463-707, Korea, Republic of
  • Department of Surgery, Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
  • Department of Surgery, Samsung Medical Center
    Seoul, 135-710, Korea, Republic of
  • Department of Surgery, Korea University Guro Hospital
    Seoul, 152-703, Korea, Republic of
  • Department of Surgery, Seoul National University Boramae Hospital
    Seoul, 156-707, 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
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References and documents

Publications

  • 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. PubMed 16003309 ↗
  • 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. doi: 10.1097/00000658-199711000-00008. PubMed 9389397 ↗
  • 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. PubMed 18535760 ↗
  • 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. PubMed 17717446 ↗
  • 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. PubMed 9923798 ↗
  • 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. PubMed 18516532 ↗
  • 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. PubMed 12413321 ↗
  • 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. PubMed 16708294 ↗
  • 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. PubMed 9230663 ↗
  • 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. PubMed 17114014 ↗
  • 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. PubMed 27040594 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01023594
Lead sponsor
Seoul National University Hospital
Responsible party
Sun-Whe Kim (Professor, Seoul National University Hospital) — Principal investigator
First posted
Dec 2, 2009
Start date
Jan 2010
Primary completion
Jan 2014
Completion
Jan 2016 (estimated)
Last update
Sep 15, 2015

Study contacts

Sun-Whe Kim, M.D.
study chair · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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