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

Primary Purpose

Pancreatic Cancer, Pancreatic Cystic Lesions, Chronic Pancreatitis

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Stapling closure of the pancreatic stump
Roux-en-Y anastomosis of the pancreatic stump
Sponsored by
Wakayama Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pancreatic Cancer focused on measuring distal pancreatectomy, pancreatic fistula, pancreaticojejunostomy, Roux-en-Y anastomosis, stapling closure

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Roux-en-Y anastomosis of the pancreatic stump

Stapling closure of the pancreatic stump

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Incidence of pancreatic fistula defined by ISGPF classification

Secondary Outcome Measures

morbidity
postoperative hospital stay
quality of life
new onset or worsening diabetes
nutritional status
mortality
Incidence of pancreatic fistula gradeB/C defined by ISGPF classification
Incidence of pancreatic fistula grade B/C stratified based on thickness of pancreas parenchyma
Incidence of pancreatic fistula stratified based on thickness of pancreas parenchyma

Full Information

First Posted
June 22, 2011
Last Updated
July 20, 2016
Sponsor
Wakayama Medical University
Collaborators
Osaka University, Nara Medical University, Kyoto Prefectural University of Medicine, Kansai Rosai Hospital, Hyogo Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01384617
Brief Title
Trial Assessing Roux-en-Y Anastomosis of the Pancreatic Stump to Prevent Pancreatic Fistula Following Distal Pancreatectomy
Official Title
Roux-en-Y Anastomosis of the Pancreatic Stump Following Distal Pancreatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wakayama Medical University
Collaborators
Osaka University, Nara Medical University, Kyoto Prefectural University of Medicine, Kansai Rosai Hospital, Hyogo Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Pancreatic Cystic Lesions, Chronic Pancreatitis, Pancreatic Neuroendocrine Tumors, Pancreatic Pseudocysts
Keywords
distal pancreatectomy, pancreatic fistula, pancreaticojejunostomy, Roux-en-Y anastomosis, stapling closure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Roux-en-Y anastomosis of the pancreatic stump
Arm Type
Experimental
Arm Description
end-to-side pancreaticojejunostomy into a retrocolic Roux-en-Y reconstruction. The pancreaticojejunostomy anastomosis is performed in duct-to-mucosa.
Arm Title
Stapling closure of the pancreatic stump
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Stapling closure of the pancreatic stump
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Roux-en-Y anastomosis of the pancreatic stump
Intervention Description
end-to-side pancreaticojejunostomy into a retrocolic Roux-en-Y reconstruction. The pancreaticojejunostomy anastomosis is performed in duct-to-mucosa.
Primary Outcome Measure Information:
Title
Incidence of pancreatic fistula defined by ISGPF classification
Time Frame
3 month after operation
Secondary Outcome Measure Information:
Title
morbidity
Time Frame
3 months after opeartion
Title
postoperative hospital stay
Time Frame
3 month after operation
Title
quality of life
Time Frame
2 years after operation
Title
new onset or worsening diabetes
Time Frame
2 years after opeartion
Title
nutritional status
Time Frame
2 years after opeartion
Title
mortality
Time Frame
3 months after operation
Title
Incidence of pancreatic fistula gradeB/C defined by ISGPF classification
Time Frame
3 months after oepration
Title
Incidence of pancreatic fistula grade B/C stratified based on thickness of pancreas parenchyma
Time Frame
3 months after oepration
Title
Incidence of pancreatic fistula stratified based on thickness of pancreas parenchyma
Time Frame
3 months after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manabu Kawai, MD
Organizational Affiliation
Wakayama Medical University, School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second Department of Surgery, Wakayama Medical University, School of Medicine
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
19434697
Citation
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.
Results Reference
background
PubMed Identifier
17414606
Citation
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.
Results Reference
background
PubMed Identifier
17458602
Citation
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.
Results Reference
background
PubMed Identifier
15852419
Citation
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.
Results Reference
background
PubMed Identifier
21529927
Citation
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.
Results Reference
result
PubMed Identifier
20538249
Citation
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.
Results Reference
result
PubMed Identifier
16003309
Citation
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.
Results Reference
result
PubMed Identifier
26473652
Citation
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.
Results Reference
derived
PubMed Identifier
23878017
Citation
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.
Results Reference
derived

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

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