PoLyglycolic Acid Felt reiNforcEmenT of the PancreaticoJejunostomy (PLANET-PJ Trial) (NCT03331718) | Clinical Trial Compass
CompletedPhase 3
PoLyglycolic Acid Felt reiNforcEmenT of the PancreaticoJejunostomy (PLANET-PJ Trial)
Japan514 participantsStarted 2018-10-10
Plain-language summary
The polyglycolic acid (PGA) felt is a felt-like absorbable suture reinforcing material. The pancreatojejunostomy aimed at reducing POPF is not established at present. We devised a new method using doubly PGA felt. This study is a multicenter, randomized phase III trial between Japan and Korea to verify the usefulness of this double coating of PGA felt.
Who can participate
Age range20 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Disease of pancreatic or periampullary lesions to require pancreatoduodenectomy
✓. Planned pancreaticojejunostomy including duct-to-mucosa anastomosis
✓. MPD diameter ≤3mm on the left side of the portal vein in preoperative imaging (CT or MRI)
✓. Performance status (ECOG scale): 0-1 at the time of enrollment
✓. Age: 20 years or older
✓. 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
✓. Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
✕. Planned pancreatogastrostomy
✕. Laparoscopic or laparoscope-assisted pancreatoduodenectomy
✕. Pancreatic parenchymal atrophy or calcification due to chronic pancreatitis
✕. Neoadjuvant treatment including chemotherapy or radiotherapy
✕. History of upper abdominal surgery (both of open and laparoscopic) except cholecystectomy
✕. Emergency operation
What they're measuring
1
Incidence of a clinically relevant POPF (ISGPS grade B/C)