Comparison of Feasibility Between Internal and External Pancreatic Drainage in Pancreaticoduodenectomy

NCT01023594 | Unknown DMC

• 1 other identifier: H-0908-040-290
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 8

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.

Conditions

Pancreatic Fistula

Keywords

Pancreatic fistula; Pancreatic leakage; Pancreatoduodenectomy; Pancreatic stent

Outcome Measures

Primary Outcomes (1)

• evidence of pancreatic fistula confirmed by serum and drain amylase

  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

  within the first 1 year after surgery

Study Arms (2)

External stent

ACTIVE COMPARATOR

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

Internal stent

ACTIVE COMPARATOR

short(5cm)internal stent insertion at pancreatojejunostomy site

Procedure: Pancreatic stent

Interventions

Pancreatic stent PROCEDURE

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.

External stent; Internal stent

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (8)

Center for Liver Cancer, National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Department of Surgery, Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Department of Surgery, Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

Department of Surgery, Samsung Medical Center

Seoul, 135-710, South Korea

Location

Department of Surgery, Korea University Guro Hospital

Seoul, 152-703, South Korea

Location

Department of Surgery, Seoul National University Boramae Hospital

Seoul, 156-707, South Korea

Location

Department of Surgery, Chung-ang University College of Medicine

Seoul, South Korea

Location

Department of Surgery, Gangnam Severance Hospital

Seoul, South Korea

Location

Related Publications (11)

• 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.

  PMID: 16003309 BACKGROUND

• 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.

  PMID: 9389397 BACKGROUND

• 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.

  PMID: 18535760 BACKGROUND

• 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: 17717446 BACKGROUND

• 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.

  PMID: 9923798 BACKGROUND

• 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.

  PMID: 18516532 BACKGROUND

• 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.

  PMID: 12413321 BACKGROUND

• 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.

  PMID: 16708294 BACKGROUND

• 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.

  PMID: 9230663 BACKGROUND

• 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.

  PMID: 17114014 BACKGROUND

• 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.

  PMID: 27040594 DERIVED

MeSH Terms

Conditions

Pancreatic Fistula

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Pancreatic Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Sun-Whe Kim, M.D.

  Seoul National University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 30, 2009
• First Posted: December 2, 2009
• Study Start: January 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2016
• Last Updated: September 15, 2015

Record last verified: 2015-09

Locations

KR (8)