Pancreatic CancerNCT01384617
Trial Assessing Roux-en-Y Anastomosis of the Pancreatic Stump to Prevent Pancreatic Fistula Following Distal Pancreatectomy
A study testing Stapling closure of the pancreatic stump and Roux-en-Y anastomosis of the pancreatic stump in people with Pancreatic Cancer and Pancreatic Cystic Lesions, run by Wakayama Medical University at 1 site in Japan.
Trial summary
The objective is to clarify Roux-en-Y anastomosis of the pancreatic stump decreases pancreatic fistula following distal pancreatectomy, compared with stapling closure of the pancreatic stump. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Cystic Lesions, Chronic Pancreatitis
- What is being tested?
- Stapling closure of the pancreatic stump and Roux-en-Y anastomosis of the pancreatic stump
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2011to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- disease of pancreatic body and tail
- PS (ECOG Performance Status Scale):0-1
- Age: 20 years or older
- distant metastases are not diagnosed preoperatively. Eligible for this clinical study when only distal pancreatectomy contributes to the favorable prognosis even if patients with pancreatic neuroendocrine cancer have the liver metastasis.
- Adequate organ functions filled the following criteria within two weeks from enrollment:
- 1.White blood cell： >3,500/mm3 or <12,000/mm3 2.Neutrophilic leukocyte >2,000/mm3 3.Platelet>100,000/mm3 4.Hemoglobin > 9.0g/dL 5.Total bilirubin <2.0mg/dL 6.AST and ALT<150IU/L 7.Creatinine <1.5mg/dL 6)Patients who can provide written informed consent
Who cannot join
- Patients with severe liver cirrhosis or active hepatitis
- Patients with respiratory illness that requires oxygen administration
- .Patients with chronic renal failure requiring dialysis
- Patients with active duplicative malignant disease affecting adverse event
- Others, patients who are unfit for the study as determined by the attending physician
Trial locations and contacts
1 site in 1 country.
Japan1 site
Second Department of Surgery, Wakayama Medical University, School of Medicine
Wakayama, 641-8510
About this study
Official title: Roux-en-Y Anastomosis of the Pancreatic Stump Following Distal Pancreatectomy
The objective is to clarify Roux-en-Y anastomosis of the pancreatic stump decreases pancreatic fistula following distal pancreatectomy, compared with stapling closure of the pancreatic stump.
Read the detailed description
The objective of this study was to clarify Roux-en-Y anastomosis of the pancreatic stump prevents pancreatic fistula after distal pancreatectomy (DP) compared to stapling closure of the pancreatic stump in a prospective randomized controlled trail.
Various methods and technique for treating surgical stump of the remnant pancreas have been reported to reduce pancreatic fistula after DP. However, appropriate surgical stump closure after DP is still controversial.
The primary endpoint in this trial was defined as the incidence of pancreatic fistula .
- Conditions
- Pancreatic Cancer, Pancreatic Cystic Lesions, Chronic Pancreatitis, Pancreatic Neuroendocrine Tumors, Pancreatic Pseudocysts
- Being tested
- Stapling closure of the pancreatic stump, Roux-en-Y anastomosis of the pancreatic stump
- Keywords
- distal pancreatectomy, pancreatic fistula, pancreaticojejunostomy, Roux-en-Y anastomosis, stapling closure
- Medical subject headings
- Pancreatic Neoplasms, Pancreatitis, Chronic, Pancreatic Pseudocyst, Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stapling closure of the pancreatic stumpProcedure or surgery
Echelon 60 with a gold cartridge provide provides precise and uniform wide compression throughout the entire 60mm length with compressible thickness to 1.8mm, which can attach two triple-staggered rows of titanium staples.
Roux-en-Y anastomosis of the pancreatic stumpProcedure or surgery
end-to-side pancreaticojejunostomy into a retrocolic Roux-en-Y reconstruction. The pancreaticojejunostomy anastomosis is performed in duct-to-mucosa.
| Study group | Role | What they receive |
|---|---|---|
| Roux-en-Y anastomosis of the pancreatic stump | Experimental | end-to-side pancreaticojejunostomy into a retrocolic Roux-en-Y reconstruction. The pancreaticojejunostomy anastomosis is performed in duct-to-mucosa. Receives: Procedure: Roux-en-Y anastomosis of the pancreatic stump |
| Stapling closure of the pancreatic stump | Active comparator | Echelon 60 with a gold cartridge provide provides precise and uniform wide compression throughout the entire 60mm length with compressible thickness to 1.8mm, which can attach two triple-staggered rows of titanium staples. Receives: Procedure: Stapling closure of the pancreatic stump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pancreatic fistula defined by ISGPF classification
Measured: 3 month after operation
Secondary outcomes (9)
morbidity
Measured: 3 months after opeartion
postoperative hospital stay
Measured: 3 month after operation
quality of life
Measured: 2 years after operation
new onset or worsening diabetes
Measured: 2 years after opeartion
nutritional status
Measured: 2 years after opeartion
mortality
Measured: 3 months after operation
Incidence of pancreatic fistula gradeB/C defined by ISGPF classification
Measured: 3 months after oepration
Incidence of pancreatic fistula grade B/C stratified based on thickness of pancreas parenchyma
Measured: 3 months after oepration
Incidence of pancreatic fistula stratified based on thickness of pancreas parenchyma
Measured: 3 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2014
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- 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
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wakayama Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Osaka University, Nara Medical University, Kyoto Prefectural University of Medicine, Kansai Rosai Hospital, Hyogo Medical University
- Responsible party
- Principal investigator, Hiroki Yamaue, Wakayama Medical University
- Investigators
- Manabu Kawai, MD, Principal investigator, Wakayama Medical University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384617
- Sponsor's protocol ID
- KNOW study-1101
- Status last verified
- Jul 2016
- First submitted
- 22 Jun 2011
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Olah A, Issekutz A, Belagyi T, Hajdu N, Romics L Jr. Randomized clinical trial of techniques for closure of the pancreatic remnant following distal pancreatectomy. Br J Surg. 2009 Jun;96(6):602-7. doi: 10.1002/bjs.6620.
PubMed 19434697Kleeff J, Diener MK, Z'graggen K, Hinz U, Wagner M, Bachmann J, Zehetner J, Muller MW, Friess H, Buchler MW. Distal pancreatectomy: risk factors for surgical failure in 302 consecutive cases. Ann Surg. 2007 Apr;245(4):573-82. doi: 10.1097/01.sla.0000251438.43135.fb.
PubMed 17414606Wagner M, Gloor B, Ambuhl M, Worni M, Lutz JA, Angst E, Candinas D. Roux-en-Y drainage of the pancreatic stump decreases pancreatic fistula after distal pancreatic resection. J Gastrointest Surg. 2007 Mar;11(3):303-8. doi: 10.1007/s11605-007-0094-2.
PubMed 17458602Knaebel HP, Diener MK, Wente MN, Buchler MW, Seiler CM. Systematic review and meta-analysis of technique for closure of the pancreatic remnant after distal pancreatectomy. Br J Surg. 2005 May;92(5):539-46. doi: 10.1002/bjs.5000.
PubMed 15852419Diener MK, Seiler CM, Rossion I, Kleeff J, Glanemann M, Butturini G, Tomazic A, Bruns CJ, Busch OR, Farkas S, Belyaev O, Neoptolemos JP, Halloran C, Keck T, Niedergethmann M, Gellert K, Witzigmann H, Kollmar O, Langer P, Steger U, Neudecker J, Berrevoet F, Ganzera S, Heiss MM, Luntz SP, Bruckner T, Kieser M, Buchler MW. Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial. Lancet. 2011 Apr 30;377(9776):1514-22. doi: 10.1016/S0140-6736(11)60237-7.
PubMed 21529927Zhou W, Lv R, Wang X, Mou Y, Cai X, Herr I. Stapler vs suture closure of pancreatic remnant after distal pancreatectomy: a meta-analysis. Am J Surg. 2010 Oct;200(4):529-36. doi: 10.1016/j.amjsurg.2009.12.022. Epub 2010 Jun 9.
PubMed 20538249Bassi 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 16003309Kawai M, Hirono S, Okada K, Sho M, Nakajima Y, Eguchi H, Nagano H, Ikoma H, Morimura R, Takeda Y, Nakahira S, Suzumura K, Fujimoto J, Yamaue H. Randomized Controlled Trial of Pancreaticojejunostomy versus Stapler Closure of the Pancreatic Stump During Distal Pancreatectomy to Reduce Pancreatic Fistula. Ann Surg. 2016 Jul;264(1):180-7. doi: 10.1097/SLA.0000000000001395.
PubMed 26473652Okada K, Kawai M, Tani M, Hirono S, Miyazawa M, Shimizu A, Kitahata Y, Yamaue H. Isolated Roux-en-Y anastomosis of the pancreatic stump in a duct-to-mucosa fashion in patients with distal pancreatectomy with en-bloc celiac axis resection. J Hepatobiliary Pancreat Sci. 2014 Mar;21(3):193-8. doi: 10.1002/jhbp.16. Epub 2013 Jul 22.
PubMed 23878017
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Roux-en-Y Anastomosis of the Pancreatic Stump Following Distal Pancreatectomy
- ClinicalTrials.gov ID
- NCT01384617
- Acronym / sponsor ID
- KNOW study-1101
- Conditions
- Pancreatic Cancer, Pancreatic Cystic Lesions, Chronic Pancreatitis, Pancreatic Neuroendocrine Tumors, Pancreatic Pseudocysts
- Keywords
- distal pancreatectomy, pancreatic fistula, pancreaticojejunostomy, Roux-en-Y anastomosis, stapling closure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Wakayama Medical UniversityUniversity, hospital or other
- Collaborators
- Osaka University, Nara Medical University, Kyoto Prefectural University of Medicine, Kansai Rosai Hospital, Hyogo Medical University
- Study start
- Jun 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 29 Jun 2011 (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.
The objective is to clarify Roux-en-Y anastomosis of the pancreatic stump decreases pancreatic fistula following distal pancreatectomy, compared with stapling closure of the pancreatic stump.
Detailed description
The objective of this study was to clarify Roux-en-Y anastomosis of the pancreatic stump prevents pancreatic fistula after distal pancreatectomy (DP) compared to stapling closure of the pancreatic stump in a prospective randomized controlled trail.
Various methods and technique for treating surgical stump of the remnant pancreas have been reported to reduce pancreatic fistula after DP. However, appropriate surgical stump closure after DP is still controversial.
The primary endpoint in this trial was defined as the incidence of pancreatic fistula .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roux-en-Y anastomosis of the pancreatic stump | Experimental | Procedure: Roux-en-Y anastomosis of the pancreatic stumpend-to-side pancreaticojejunostomy into a retrocolic Roux-en-Y reconstruction. The pancreaticojejunostomy anastomosis is performed in duct-to-mucosa. |
| Stapling closure of the pancreatic stump | Active comparator | Procedure: Stapling closure of the pancreatic stumpEchelon 60 with a gold cartridge provide provides precise and uniform wide compression throughout the entire 60mm length with compressible thickness to 1.8mm, which can attach two triple-staggered rows of titanium staples. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- disease of pancreatic body and tail
- PS (ECOG Performance Status Scale):0-1
- Age: 20 years or older
- distant metastases are not diagnosed preoperatively. Eligible for this clinical study when only distal pancreatectomy contributes to the favorable prognosis even if patients with pancreatic neuroendocrine cancer have the liver metastasis.
- Adequate organ functions filled the following criteria within two weeks from enrollment:
Key exclusion criteria (5 listed)
- Patients with severe liver cirrhosis or active hepatitis
- Patients with respiratory illness that requires oxygen administration
- .Patients with chronic renal failure requiring dialysis
- Patients with active duplicative malignant disease affecting adverse event
- Others, patients who are unfit for the study as determined by the attending physician
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 |
|---|---|---|
| Stapling closure of the pancreatic stumpEchelon 60 with a gold cartridge provide provides precise and uniform wide compression throughout the entire 60mm length with compressible thickness to 1.8mm, which can attach two triple-staggered rows of titanium staples. | Procedure or surgery | Stapling closure of the pancreatic stump |
| Roux-en-Y anastomosis of the pancreatic stumpend-to-side pancreaticojejunostomy into a retrocolic Roux-en-Y reconstruction. The pancreaticojejunostomy anastomosis is performed in duct-to-mucosa. | Procedure or surgery | Roux-en-Y anastomosis of the pancreatic stump |
Primary outcome
Incidence of pancreatic fistula defined by ISGPF classification
Time frame: 3 month after operation
9 secondary outcomes
morbidity
Time frame: 3 months after opeartion
postoperative hospital stay
Time frame: 3 month after operation
quality of life
Time frame: 2 years after operation
new onset or worsening diabetes
Time frame: 2 years after opeartion
nutritional status
Time frame: 2 years after opeartion
mortality
Time frame: 3 months after operation
Incidence of pancreatic fistula gradeB/C defined by ISGPF classification
Time frame: 3 months after oepration
Incidence of pancreatic fistula grade B/C stratified based on thickness of pancreas parenchyma
Time frame: 3 months after oepration
Incidence of pancreatic fistula stratified based on thickness of pancreas parenchyma
Time frame: 3 months after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2016.
- Background: PubMed 19434697Olah A, Issekutz A, Belagyi T, Hajdu N, Romics L Jr. Randomized clinical trial of techniques for closure of the pancreatic remnant following distal pancreatectomy. Br J Surg. 2009 Jun;96(6):602-7. doi: 10.1002/bjs.6620.
- Background: PubMed 17414606Kleeff J, Diener MK, Z'graggen K, Hinz U, Wagner M, Bachmann J, Zehetner J, Muller MW, Friess H, Buchler MW. Distal pancreatectomy: risk factors for surgical failure in 302 consecutive cases. Ann Surg. 2007 Apr;245(4):573-82. doi: 10.1097/01.sla.0000251438.43135.fb.
- Background: PubMed 17458602Wagner M, Gloor B, Ambuhl M, Worni M, Lutz JA, Angst E, Candinas D. Roux-en-Y drainage of the pancreatic stump decreases pancreatic fistula after distal pancreatic resection. J Gastrointest Surg. 2007 Mar;11(3):303-8. doi: 10.1007/s11605-007-0094-2.
- Background: PubMed 15852419Knaebel HP, Diener MK, Wente MN, Buchler MW, Seiler CM. Systematic review and meta-analysis of technique for closure of the pancreatic remnant after distal pancreatectomy. Br J Surg. 2005 May;92(5):539-46. doi: 10.1002/bjs.5000.
- Results publication: PubMed 21529927Diener MK, Seiler CM, Rossion I, Kleeff J, Glanemann M, Butturini G, Tomazic A, Bruns CJ, Busch OR, Farkas S, Belyaev O, Neoptolemos JP, Halloran C, Keck T, Niedergethmann M, Gellert K, Witzigmann H, Kollmar O, Langer P, Steger U, Neudecker J, Berrevoet F, Ganzera S, Heiss MM, Luntz SP, Bruckner T, Kieser M, Buchler MW. Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial. Lancet. 2011 Apr 30;377(9776):1514-22. doi: 10.1016/S0140-6736(11)60237-7.
- Results publication: PubMed 20538249Zhou W, Lv R, Wang X, Mou Y, Cai X, Herr I. Stapler vs suture closure of pancreatic remnant after distal pancreatectomy: a meta-analysis. Am J Surg. 2010 Oct;200(4):529-36. doi: 10.1016/j.amjsurg.2009.12.022. Epub 2010 Jun 9.
- Results publication: 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.
- Derived from this study: PubMed 26473652Kawai M, Hirono S, Okada K, Sho M, Nakajima Y, Eguchi H, Nagano H, Ikoma H, Morimura R, Takeda Y, Nakahira S, Suzumura K, Fujimoto J, Yamaue H. Randomized Controlled Trial of Pancreaticojejunostomy versus Stapler Closure of the Pancreatic Stump During Distal Pancreatectomy to Reduce Pancreatic Fistula. Ann Surg. 2016 Jul;264(1):180-7. doi: 10.1097/SLA.0000000000001395.
- Derived from this study: PubMed 23878017Okada K, Kawai M, Tani M, Hirono S, Miyazawa M, Shimizu A, Kitahata Y, Yamaue H. Isolated Roux-en-Y anastomosis of the pancreatic stump in a duct-to-mucosa fashion in patients with distal pancreatectomy with en-bloc celiac axis resection. J Hepatobiliary Pancreat Sci. 2014 Mar;21(3):193-8. doi: 10.1002/jhbp.16. Epub 2013 Jul 22.
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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.
Manabu Kawai, MD principal investigator
Wakayama Medical University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stapling closure of the pancreatic stump and Roux-en-Y anastomosis of the pancreatic stump in people with Pancreatic Cancer and Pancreatic Cystic Lesions, run by Wakayama Medical University at 1 site in Japan.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 21 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of pancreatic fistula defined by ISGPF classification (time frame: 3 month after operation). 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 NCT01384617, which also lists 9 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 21 Jul 2016.