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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

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:

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

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

NCT ID

NCT01384617

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

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

Intervention Type

Procedure

Intervention Name(s)

Stapling closure of the pancreatic stump

Intervention Description

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

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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