Pancreatic FistulaNCT01023594
Comparison of Feasibility Between Internal and External Pancreatic Drainage in Pancreaticoduodenectomy
A study testing Pancreatic stent in people with Pancreatic Fistula, run by Seoul National University Hospital at 8 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Pancreatic Fistula
- What is being tested?
- Pancreatic stent
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 8 sitesSouth Korea
- Study dates
- Jan 2010to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient who have malignant or benign disease which needs pancreatoduodenectomy
- patient age: ≥20 and ≤85
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
South Korea8 sites
Center for Liver Cancer, National Cancer Center
Goyang-si, Gyeonggi-do, 410-769
Department of Surgery, Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Department of Surgery, Seoul National University Hospital
Seoul, Seoul, 110-744
Department of Surgery, Samsung Medical Center
Seoul, 135-710
Department of Surgery, Korea University Guro Hospital
Seoul, 152-703
Department of Surgery, Seoul National University Boramae Hospital
Seoul, 156-707
Department of Surgery, Chung-ang University College of Medicine
Seoul
Department of Surgery, Gangnam Severance Hospital
Seoul
About this study
Official title: Comparison of Feasibility Between Internal and External Pancreatic Drainage in Pancreaticoduodenectomy: Prospective Randomized Study
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
- Being tested
- Pancreatic stent
- Keywords
- Pancreatic fistula, Pancreatic leakage, Pancreatoduodenectomy, Pancreatic stent
- Medical subject headings
- Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatic stentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Pancreatic stent |
| Internal stent | Active comparator | short(5cm)internal stent insertion at pancreatojejunostomy site Receives: Procedure: Pancreatic stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
evidence of pancreatic fistula confirmed by serum and drain amylase
Measured: 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
Measured: within the first 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionJan 2014
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pancreatic FistulaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun-Whe Kim, Seoul National University Hospital
- Investigators
- Sun-Whe Kim, M.D., Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023594
- Sponsor's protocol ID
- H-0908-040-290
- Status last verified
- Sep 2015
- First submitted
- 30 Nov 2009
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
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 16003309Lowy 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 9389397Butturini 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 18535760Poon 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 17717446Roder 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 9923798Kamoda 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 18516532Ohwada 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 12413321Imaizumi 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 16708294Kim 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 9230663Winter 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 17114014Jang 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Feasibility Between Internal and External Pancreatic Drainage in Pancreaticoduodenectomy: Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01023594
- Acronym / sponsor ID
- H-0908-040-290
- Conditions
- Pancreatic Fistula
- Keywords
- Pancreatic fistula, Pancreatic leakage, Pancreatoduodenectomy, Pancreatic stent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2016 (estimated)
- First posted
- 2 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External stent | Active comparator | Procedure: Pancreatic stentFeeding tube insert at pancreatojejunostomy site as a stent. And stent tube is brought out through jejunal loop below the hepaticojejunostomy site and abdominal wall. |
| Internal stent | Active comparator | Procedure: Pancreatic stentshort(5cm)internal stent insertion at pancreatojejunostomy site |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient who have malignant or benign disease which needs pancreatoduodenectomy
- patient age: ≥20 and ≤85
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pancreatic stentFeeding 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. | Procedure or surgery | External stent, Internal stent |
Primary outcome
evidence of pancreatic fistula confirmed by serum and drain amylase
Time frame: within the first 7 days after surgery
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2015.
- Background: PubMed 16003309Bassi 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.
- Background: PubMed 9389397Lowy 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.
- Background: PubMed 18535760Butturini 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.
- Background: PubMed 17717446Poon 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.
- Background: PubMed 9923798Roder 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.
- Background: PubMed 18516532Kamoda 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.
- Background: PubMed 12413321Ohwada 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.
- Background: PubMed 16708294Imaizumi 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.
- Background: PubMed 9230663Kim 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.
- Background: PubMed 17114014Winter 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.
- Derived from this study: PubMed 27040594Jang 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.
Related trials for Pancreatic Fistula
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
RecruitingObservational study
Management and Outcomes of Local Complications of Acute Pancreatitis and Postoperative Pancreatic Fistula
Acute Pancreatitis, Pancreatic Fluid Collection
Not yet recruitingObservational study
Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy
Pancreaticoduodenectomy
Recruiting
Tissue Adhesive Glue Modified Cyanoacrylate (Glubran® 2) in Soft Pancreas
Pancreatic Cancer, Periampullary Cancer
Not yet recruitingObservational study
Predicting Pancreatic Fistula After Pancreatic Surgery Using Preoperative Immunity
Pancreatic Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sun-Whe Kim, M.D. study chair
Seoul National University Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pancreatic stent in people with Pancreatic Fistula, run by Seoul National University Hospital at 8 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evidence of pancreatic fistula confirmed by serum and drain amylase (time frame: within the first 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01023594, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2015.