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

This study is currently recruiting participants.
Verified June 2011 by Wakayama Medical University
Sponsor:
Collaborators:
Osaka University
Nara Medical University
Kyoto Prefectural University of Medicine
Kansai Rosai Hospital
Information provided by:
Wakayama Medical University
ClinicalTrials.gov Identifier:
NCT01384617
First received: June 22, 2011
Last updated: June 27, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Roux-en-Y Anastomosis of the Pancreatic Stump Following Distal Pancreatectomy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wakayama Medical University:

Primary Outcome Measures:
  • Incidence of pancreatic fistula defined by ISGPF classification [ Time Frame: 1 month after operation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • morbidity [ Time Frame: 3 months after opeartion ] [ Designated as safety issue: Yes ]
  • postoperative hospital stay [ Time Frame: 1 month after operation ] [ Designated as safety issue: Yes ]
  • quality of life [ Time Frame: 2 years after operation ] [ Designated as safety issue: Yes ]
  • new onset or worsening diabetes [ Time Frame: 2 years after opeartion ] [ Designated as safety issue: Yes ]
  • nutritional status [ Time Frame: 2 years after opeartion ] [ Designated as safety issue: Yes ]
  • mortality [ Time Frame: 3 months after operation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 136
Study Start Date: June 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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 .

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. Patients with laparoscopic distal pancreatectomy
  6. Others, patients who are unfit for the study as determined by the attending physician
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384617

Contacts
Contact: Hiroki Yamaue, MD +81-73-441-0612 yamaue-h@wakayama-med.ac.jp

Locations
Japan
Second Department of Surgery, Wakayama Medical University, School of Medicine Recruiting
811-1 Kimiidera, Wakayama City, Japan, 641-8510
Contact: Hiroki Yamaue, MD     +81-73-441-0612     yamaue-h@wakayama-med.ac.jp    
Principal Investigator: Manabu Kawai, MD            
Principal Investigator: Ken-ichi Okada, MD            
Sponsors and Collaborators
Wakayama Medical University
Osaka University
Nara Medical University
Kyoto Prefectural University of Medicine
Kansai Rosai Hospital
Investigators
Principal Investigator: Manabu Kawai, MD Wakayama Medical University, School of Medicine
  More Information

Publications:

Responsible Party: Second Department of Surgery, Wakayama Medical University School of Medicine
ClinicalTrials.gov Identifier: NCT01384617     History of Changes
Other Study ID Numbers: KNOW study-1101
Study First Received: June 22, 2011
Last Updated: June 27, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Wakayama Medical University:
distal pancreatectomy
pancreatic fistula
pancreaticojejunostomy
Roux-en-Y anastomosis
stapling closure

Additional relevant MeSH terms:
Pancreatic Fistula
Pancreatic Neoplasms
Pancreatic Pseudocyst
Pancreatitis
Pancreatitis, Chronic
Neuroendocrine Tumors
Adenoma, Islet Cell
Digestive System Fistula
Digestive System Diseases
Pancreatic Diseases
Fistula
Pathological Conditions, Anatomical
Digestive System Neoplasms
 Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Pancreatic Cyst
Cysts
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Adenoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 22, 2013