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Efficacy of polyglycolic acid felt in prevention of pancreatic fistula after distal pancreatectomy

Efficacy of polyglycolic acid felt in prevention of pancreatic fistula after distal pancreatectomy - Efficacy of polyglycolic acid felt in prevention of pancreatic fistula after distal pancreatectomy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000017156
Enrollment
30
Registered
2015-04-30
Start date
2015-02-23
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients undergoing distal pancreatectomy

Interventions

1)The pancreas transection are performed using the Endoscopic linear Cutter Echelon 60TM (EC60A), green cartridge (ECR60G).The closure jaw of the staple are clamped carefully and slowly at a fixed spe

Sponsors

Multicenter Clinical Study Group of Osaka
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) The distal pancreatectomy cases against pancreatic tail region diseases, including inflammatory diseases, such as tumor-forming pancreatitis. 2) the presence or absence of the presence or absence spleen preservation of vascular resection does not matter. 3) Cases we planed to use a patch of PGA felt as pancreatic stump treatment. 4) Preoperative ECOG of Performance Status (PS) is 0-1. 5) Older than 20 years old 6) Cases that do not recognize the obvious distant metastases at inspection. 7) Major organ function is preserved. Patients meet all of the following in the 14 days prior and subsequent inspection of the registration date. 1. white blood cell (WBC): 2,000 / mm3 < WBC <12,000 / mm3 2. neutrophil count (Neut): Neut > 1,000 / mm3 3. hemoglobin (Hb): Hb > 9.0 g / dL 4. platelet count (Plt): Plt > 80,000 / mm3 5. serum total bilirubin (TB): TB < 2.0 mg / dL 6. serum AST: AST < 150 IU / L 7. serum ALT: ALT < 150 IU / L 8. serum creatinine (Cr): Cr < 1.5mg / dL 9. serum albumin (Alb): Alb > 2.5 g / dL 8) consent from patients have been obtained in writing.

Exclusion criteria

Exclusion criteria: 1) Patients with a history of hypersensitivity to components of PGA felt. 2) Cases with serious complications such as heart disease and kidney disease. 3) Drug abusers, mentally unstable patients, and patients judged difficult to communicate with physicians. 4) Pregnant women or women who may possibly be pregnant. 5) Patients undergoing treatment with aprotinin, procoagulant and anti-thrombolytic agents are excluded because there is a possibility that appears thrombophilia may occur by using a tissue adhesive. 6) Patient judged inadguate.

Design outcomes

Primary

MeasureTime frame
The frequency of occurrence of pancreatic fistula

Secondary

MeasureTime frame
morbidity, mortality, postoperative hospital stay and the incidence of late pancreatic pseudocyst

Countries

Japan

Contacts

Public ContactHidetoshi Eguchi

Osaka University, Graduate School of Medicine Department of Gastroenterological Surgery

thata20@gesurg.med.osaka-u.ac.jp06-6879-3251

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026