New felt patch may cut dangerous pancreatic leaks after surgery
NCT ID NCT03331718
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a special absorbable felt (PGA felt) placed around the new connection made during pancreatic surgery can reduce dangerous leaks. Over 500 patients in Japan and Korea took part. The goal was to see if this simple reinforcement lowers the chance of a serious pancreatic fluid leak after the operation.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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514 people
The number who actually took part.
- Started
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Oct 2018
- Finished
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Jan 2022
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Disease of pancreatic or periampullary lesions to require pancreatoduodenectomy 2. Planned pancreaticojejunostomy including duct-to-mucosa anastomosis 3. MPD diameter ≤3mm on the left side of the portal vein in preoperative imaging (CT or MRI) 4. Performance status (ECOG scale): 0-1 at the time of enrollment 5. Age: 20 years or older 6. Adequate organ function A) Leukocyte count: ≥2500 mm3, ≤14000 mm3 B) Hemoglobin: ≥9.0 g/dL C) Platelet count: ≥100,000 mm3 D) Total Bilirubin: ≤2.0 mg/dL (not apply to cases with obstructive jaundice) E) Creatinine: ≤2.0 mg/dL 7. Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: 1. Planned pancreatogastrostomy 2. Laparoscopic or laparoscope-assisted pancreatoduodenectomy 3. Pancreatic parenchymal atrophy or calcification due to chronic pancreatitis 4. Neoadjuvant treatment including chemotherapy or radiotherapy 5. History of upper abdominal surgery (both of open and laparoscopic) except cholecystectomy 6. Emergency operation 7. Arterial reconstruction such as superior mesenteric artery, common hepatic artery, or celiac artery 8. Severe ischemic heart disease 9. Severe liver dysfunction due to liver cirrhosis or active hepatitis 10. Severe respiratory disorder required oxygen inhalation 11. Chronic renal failure with dialysis 12. Requiring resection of other organs (liver or colon) during pancreatoduodenectomy 13. Immunosuppressive treatment 14. History of severe hypersensitivity to PGA felt and fibrin glue 15. Other severe drug allergies 16. Contrast media allergy of both iodine and gadolinium 17. Active duplicate cancer thought to affect adverse events 18. Severe psychological or neurological disease 19. Drug abuse or alcoholics 20. Planned use of octreotide
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Toyama
Toyama, Toyama, 9300194, Japan