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Clinical Trial Record

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Trial Assessing Roux-en-Y Anastomosis of the Pancreatic Stump to Prevent Pancreatic Fistula Following Distal Pancreatectomy

2011-06

2014-06

2016-06

136

Study Overview

Trial Assessing Roux-en-Y Anastomosis of the Pancreatic Stump to Prevent Pancreatic Fistula 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.

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 .

  • Pancreatic Cancer
  • Pancreatic Cystic Lesions
  • Chronic Pancreatitis
  • Pancreatic Neuroendocrine Tumors
  • Pancreatic Pseudocysts
  • PROCEDURE: Stapling closure of the pancreatic stump
  • PROCEDURE: Roux-en-Y anastomosis of the pancreatic stump
  • KNOW study-1101

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2011-06-22  

N/A  

2016-07-20  

2011-06-27  

N/A  

2016-07-21  

2011-06-29  

N/A  

2016-07  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Prevention

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Roux-en-Y anastomosis of the pancreatic stump

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

  • end-to-side pancreaticojejunostomy into a retrocolic Roux-en-Y reconstruction. The pancreaticojejunostomy anastomosis is performed in duct-to-mucosa.
ACTIVE_COMPARATOR: Stapling closure of the pancreatic stump

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

  • 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.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Incidence of pancreatic fistula defined by ISGPF classification3 month after operation
Secondary Outcome MeasuresMeasure DescriptionTime Frame
morbidity3 months after opeartion
postoperative hospital stay3 month after operation
quality of life2 years after operation
new onset or worsening diabetes2 years after opeartion
nutritional status2 years after opeartion
mortality3 months after operation
Incidence of pancreatic fistula gradeB/C defined by ISGPF classification3 months after oepration
Incidence of pancreatic fistula grade B/C stratified based on thickness of pancreas parenchyma3 months after oepration
Incidence of pancreatic fistula stratified based on thickness of pancreas parenchyma3 months after operation

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. disease of pancreatic body and tail 2. PS (ECOG Performance Status Scale):0-1 3. Age: 20 years or older 4. 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. 5. 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
    Exclusion Criteria:
    1. Patients with severe liver cirrhosis or active hepatitis 2. Patients with respiratory illness that requires oxygen administration 3. .Patients with chronic renal failure requiring dialysis 4. Patients with active duplicative malignant disease affecting adverse event 5. Others, patients who are unfit for the study as determined by the attending physician

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Osaka University
  • Nara Medical University
  • Kyoto Prefectural University of Medicine
  • Kansai Rosai Hospital
  • Hyogo Medical University
  • PRINCIPAL_INVESTIGATOR: Manabu Kawai, MD, Wakayama Medical University, School of Medicine

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
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