New felt patch may cut dangerous pancreatic leaks after surgery

NCT ID NCT03331718

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

514 people

The number who actually took part.

Started

Oct 2018

Finished

Jan 2022

Lead sponsor

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

20 years and older

Sex

Anyone

Healthy volunteers

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

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Disease of pancreatic or periampullary lesions are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

Pancreatic Fistula

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Toyama

    Toyama, Toyama, 9300194, Japan