NCT01384617

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable pancreatic-cancer

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 29, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 21, 2016

Status Verified

July 1, 2016

Enrollment Period

3 years

First QC Date

June 22, 2011

Last Update Submit

July 20, 2016

Conditions

Pancreatic CancerPancreatic Cystic LesionsChronic PancreatitisPancreatic Neuroendocrine TumorsPancreatic Pseudocysts

Keywords

distal pancreatectomypancreatic fistulapancreaticojejunostomyRoux-en-Y anastomosisstapling closure

Outcome Measures

Primary Outcomes (1)

  • Incidence of pancreatic fistula defined by ISGPF classification

    3 month after operation

Secondary Outcomes (9)

  • morbidity

    3 months after opeartion

  • postoperative hospital stay

    3 month after operation

  • quality of life

    2 years after operation

  • new onset or worsening diabetes

    2 years after opeartion

  • nutritional status

    2 years after opeartion

  • +4 more secondary outcomes

Study Arms (2)

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.

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.

Procedure: Stapling closure of the pancreatic stump

Interventions

Stapling closure of the pancreatic stumpPROCEDURE

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.

Stapling closure of the pancreatic stump
Roux-en-Y anastomosis of the pancreatic stumpPROCEDURE

end-to-side pancreaticojejunostomy into a retrocolic Roux-en-Y reconstruction. The pancreaticojejunostomy anastomosis is performed in duct-to-mucosa.

Roux-en-Y anastomosis of the pancreatic stump

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Department of Surgery, Wakayama Medical University, School of Medicine

Wakayama, 641-8510, Japan

Location

Related Publications (9)

  • 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.

    PMID: 19434697BACKGROUND

  • Kleeff 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.

    PMID: 17414606BACKGROUND

  • Wagner 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.

    PMID: 17458602BACKGROUND

  • Knaebel 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.

    PMID: 15852419BACKGROUND

  • Diener 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.

    PMID: 21529927RESULT

  • Zhou 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.

    PMID: 20538249RESULT

  • 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: 16003309RESULT

  • Kawai 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.

    PMID: 26473652DERIVED

  • Okada 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.

    PMID: 23878017DERIVED

MeSH Terms

Conditions

Pancreatic NeoplasmsPancreatitis, ChronicPancreatic PseudocystPancreatic Fistula

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesPancreatitisChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPancreatic CystCystsDigestive System FistulaFistulaPathological Conditions, Anatomical

Study Officials

  • Manabu Kawai, MD

    Wakayama Medical University, School of Medicine

    PRINCIPAL INVESTIGATOR

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
Second Department of Surgery

Study Record Dates

First Submitted

June 22, 2011

First Posted

June 29, 2011

Study Start

June 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2016

Last Updated

July 21, 2016

Record last verified: 2016-07

Locations

JP(1)