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

Pancreatic Cancer Clinical Trial

Official title:

Roux-en-Y Anastomosis of the Pancreatic Stump Following Distal Pancreatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01384617
• Other study ID #: KNOW study-1101
• Status: Completed
• Phase: N/A
• First received: June 22, 2011
• Last updated: July 20, 2016
• Start date: June 2011
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Wakayama Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: June 2016
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carcinoid Tumor
• Chronic Pancreatitis
• Neuroendocrine Tumors
• Pancreatic Cancer
• Pancreatic Cystic Lesions
• Pancreatic Fistula
• Pancreatic Neoplasms
• Pancreatic Neuroendocrine Tumors
• Pancreatic Pseudocyst
• Pancreatic Pseudocysts
• Pancreatitis
• Pancreatitis, Chronic

Intervention

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.
• 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.

Locations

Country	Name	City	State
Japan	Second Department of Surgery, Wakayama Medical University, School of Medicine	Wakayama

Sponsors (6)

Lead Sponsor	Collaborator
Wakayama Medical University	Hyogo College of Medicine, Kansai Rosai Hospital, Kyoto Prefectural University of Medicine, Nara Medical University, Osaka University

Country where clinical trial is conducted

Japan, 

References & Publications (7)

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. S — View 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 — View Citation

Kleeff J, Diener MK, Z'graggen K, Hinz U, Wagner M, Bachmann J, Zehetner J, Müller MW, Friess H, Büchler MW. Distal pancreatectomy: risk factors for surgical failure in 302 consecutive cases. Ann Surg. 2007 Apr;245(4):573-82. — View Citation

Knaebel HP, Diener MK, Wente MN, Büchler 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. Review. — View Citation

Oláh A, Issekutz A, Belágyi T, Hajdú 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. — View Citation

Wagner M, Gloor B, Ambühl 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of pancreatic fistula defined by ISGPF classification		3 month after operation	Yes
Secondary	morbidity		3 months after opeartion	Yes
Secondary	postoperative hospital stay		3 month after operation	Yes
Secondary	quality of life		2 years after operation	Yes
Secondary	new onset or worsening diabetes		2 years after opeartion	Yes
Secondary	nutritional status		2 years after opeartion	Yes
Secondary	mortality		3 months after operation	Yes
Secondary	Incidence of pancreatic fistula gradeB/C defined by ISGPF classification		3 months after oepration	Yes
Secondary	Incidence of pancreatic fistula grade B/C stratified based on thickness of pancreas parenchyma		3 months after oepration	Yes
Secondary	Incidence of pancreatic fistula stratified based on thickness of pancreas parenchyma		3 months after operation	Yes