Disease of Pancreatic or Periampullary Lesions Clinical Trial
Official title:
PoLyglycolic Acid Felt reiNforcEmenT of the PancreaticoJejunostomy; Multicenter Prospective Randomized Phase III Trial in Japan and Korea (PLANET-PJ Trial)
| Verified date | May 2023 |
| Source | University of Toyama |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 514 |
| Est. completion date | December 31, 2024 |
| Est. primary completion date | December 31, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Japan | University of Toyama | Toyama |
| Lead Sponsor | Collaborator |
|---|---|
| University of Toyama | Gangnam Severance Hospital, Kansai Medical University, Kumamoto University, Nagoya University, Nara Medical University, National Cancer Center, Korea, Osaka City University, Osaka University, Samsung Medical Center, Seoul National University Bundang Hospital, Seoul National University Hospital, Severance Hospital, Shiga Medical University, Shimane University, Tokyo Medical and Dental University, Tokyo Medical University, Wakayama Medical University |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of a clinically relevant POPF (ISGPS grade B/C) | Incidence of a clinically relevant POPF (grade B/C), according to the ISGPS criteria which is the evaluation criteria for POPF | within 3 months after surgery | |
| Secondary | Length of drain placement | Number of days from operation date to drain removal date (the peripancreatic drain to be removed last) | within 3 months after surgery | |
| Secondary | Length of the hospital stay | Number of days from operation date to discharge date | within 3 months after surgery | |
| Secondary | Incidence of overall POPF (Biochemical leak, grade B, and C) | Incidence of overall POPF of biochemical leak, grade B, or grade C, according to the ISGPS criteria | within 3 months after surgery | |
| Secondary | Incidence of POPF by each suturing method to approximate the pancreas and the jejunum | Incidence of overall POPF of biochemical leak, grade B, or grade C, according to the ISGPS criteria by each suturing method to approximate the pancreas and the jejunum (Kakita, two-layer, or Blumgart) | within 3 months after surgery | |
| Secondary | Incidence of delayed gastric emptying (DGE) | Incidence of overall DGE, according to the ISGPS criteria | within 3 months after surgery | |
| Secondary | Incidence of intraabdominal abscess | Incidence of intraabdominal abscess of Grade II (requiring pharmacological treatment with drugs) or more, according to Clavien-Dindo classification | within 3 months after surgery | |
| Secondary | Incidence of postpancreatectomy hemorrhage (PPH) | Incidence of overall PPH, according to the ISGPS criteria | within 3 months after surgery | |
| Secondary | Incidence of interventional drainage | Incidence of additional drainage percutaneously or endoscopically | within 3 months after surgery | |
| Secondary | Incidence of overall postoperative complications | Incidence of overall postoperative complications, according to Clavien-Dindo classification | within 3 months after surgery | |
| Secondary | Incidence of POPF-related complications (POPF+DGE+abscess+PPH) | Incidence of cases in whom one of 3), 5), 6) or 7) occurred | within 3 months after surgery | |
| Secondary | Incidence of 3-month mortality | Incidence of surgery-related deaths from operation date to postoperative 3 months | within 3 months after surgery | |
| Secondary | Incidence of reoperation | Incidence of reoperation from operation date to postoperative 3 months | within 3 months after surgery | |
| Secondary | Incidence of readmission | Incidence of readmission from operation date to postoperative 3 months | within 3 months after surgery |