Disease of Pancreatic or Periampullary Lesions
Conditions
Keywords
pancreatoduodenectomy, pancreaticojejunostomy, polyglycolic acid, Neoveil, pancreatic fistula, pancreas
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 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.
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 kinds of pancreatojejunostomy have been reported for the purpose of lowering the frequency of POPF; however, the frequency of more than grade B POPF is still around 10 to 20%. In soft pancreas cases with unexpanded pancreatic ducts, the risk is further elevated. The polyglycolic acid (PGA) felt is an absorbable suture reinforcing material. It is generally used to reinforce sutures of fragile tissues such as the lung, bronchi, liver, and gastrointestinal tract, and to reinforce a wide range of tissue defects. Regarding pancreatojejunostomy using a PGA felt, the incidence of POPF formation was decreased in some retrospective studies; on the other hand, no significant difference was found in other study. As described above, 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.
Interventions
DRUGPGA felt reinforcement
During pancreaticojejunostomy, 1) a 0.3 mm thick PGA felt (Neoveil®, Gunze, Japan) is pasted on the ventral side and the dorsal side of pancreatic parenchyma, through which suture between pancreatic parenchyma and jejunum is performed. 2) Before abdominal closure (after completion of all reconstruction, after washing in the abdominal cavity), a 0.15 mm thick PGA felt is further covered around the anastomotic site and fibrin glue is sprayed.
Sponsors
University of Toyama
Seoul National University Hospital
Kansai Medical University
Kumamoto University
Nagoya University
Nara Medical University
Osaka City University
Osaka University
Shiga Medical University
Shimane University
Tokyo Medical and Dental University
Tokyo Medical University
Wakayama Medical University
Gangnam Severance Hospital
National Cancer Center, Korea
Samsung Medical Center
Seoul National University Bundang Hospital
Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of a clinically relevant POPF (ISGPS grade B/C) | within 3 months after surgery | Incidence of a clinically relevant POPF (grade B/C), according to the ISGPS criteria which is the evaluation criteria for POPF |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of drain placement | within 3 months after surgery | Number of days from operation date to drain removal date (the peripancreatic drain to be removed last) |
| Length of the hospital stay | within 3 months after surgery | Number of days from operation date to discharge date |
| Incidence of overall POPF (Biochemical leak, grade B, and C) | within 3 months after surgery | Incidence of overall POPF of biochemical leak, grade B, or grade C, according to the ISGPS criteria |
| Incidence of POPF by each suturing method to approximate the pancreas and the jejunum | within 3 months after surgery | 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) |
| Incidence of delayed gastric emptying (DGE) | within 3 months after surgery | Incidence of overall DGE, according to the ISGPS criteria |
| Incidence of intraabdominal abscess | within 3 months after surgery | Incidence of intraabdominal abscess of Grade II (requiring pharmacological treatment with drugs) or more, according to Clavien-Dindo classification |
| Incidence of postpancreatectomy hemorrhage (PPH) | within 3 months after surgery | Incidence of overall PPH, according to the ISGPS criteria |
| Incidence of interventional drainage | within 3 months after surgery | Incidence of additional drainage percutaneously or endoscopically |
| Incidence of overall postoperative complications | within 3 months after surgery | Incidence of overall postoperative complications, according to Clavien-Dindo classification |
| Incidence of POPF-related complications (POPF+DGE+abscess+PPH) | within 3 months after surgery | Incidence of cases in whom one of 3), 5), 6) or 7) occurred |
| Incidence of 3-month mortality | within 3 months after surgery | Incidence of surgery-related deaths from operation date to postoperative 3 months |
| Incidence of reoperation | within 3 months after surgery | Incidence of reoperation from operation date to postoperative 3 months |
| Incidence of readmission | within 3 months after surgery | Incidence of readmission from operation date to postoperative 3 months |
Countries
Japan
Contacts
PRINCIPAL_INVESTIGATORTsutomu Fujii, MD, PhD
University of Toyama
Outcome results
None listed