Status:
UNKNOWN
PoLyglycolic Acid Felt reiNforcEmenT of the PancreaticoJejunostomy (PLANET-PJ Trial)
Lead Sponsor:
University of Toyama
Collaborating Sponsors:
Seoul National University Hospital
Kansai Medical University
Conditions:
Disease of Pancreatic or Periampullary Lesions
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief 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 dou...
Detailed Description
Pancreatojejunostomy is generally a combination of suture between the pancreatic parenchyma and the seromuscular layer of the jejunum, and duct-to-mucosa suture. The clinical study about the various k...
Eligibility Criteria
Inclusion
- 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
- 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
- Arterial reconstruction such as superior mesenteric artery, common hepatic artery, or celiac artery
- Severe ischemic heart disease
- Severe liver dysfunction due to liver cirrhosis or active hepatitis
- Severe respiratory disorder required oxygen inhalation
- Chronic renal failure with dialysis
- Requiring resection of other organs (liver or colon) during pancreatoduodenectomy
- Immunosuppressive treatment
- History of severe hypersensitivity to PGA felt and fibrin glue
- Other severe drug allergies
- Contrast media allergy of both iodine and gadolinium
- Active duplicate cancer thought to affect adverse events
- Severe psychological or neurological disease
- Drug abuse or alcoholics
- Planned use of octreotide
Key Trial Info
Start Date :
October 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
514 Patients enrolled
Trial Details
Trial ID
NCT03331718
Start Date
October 10 2018
End Date
December 31 2024
Last Update
May 10 2023
Active Locations (1)
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1
University of Toyama
Toyama, Japan, 9300194