Patients who are scheduled to undergo pancreatoduodenectomy for disease of pancreatic or periampullary lesions
Conditions
Interventions
Interventional group: PGA mesh reinforcement in pancreaticojejunostomy in patients undergoing pancreatoduodenectomy
Control group: pancreaticojejunostomy in patients undergoing pancreatoduodenectomy
Sponsors
Department of Surgery and Science, Faculty of Medicine, Academic Assembly, University of Toyama
Osaka Medical University, Osaka University, Kansai Medical University, Kumamoto University, Shiga Medical University, Shimane University, Tokyo Medical University, Tokyo Medical and Dental University, Nara Medical University, Nagoya University, Wakayama Medical University, Seoul National University Hospital, Gangnam Severance Hospital, Yonsei University College of Medicine, National Cancer Center, Samsung Medical Center, Seoul National University Bundang Hospital, Severance Hospital, Yonsei Univ
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 mesh 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 |
|---|---|
| Incidence of a clinically relevant POPF grade B or C by the International Study Group of Pancreatic Surgery (ISGPS) criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| Length of the drain placement Length of the hospital stay Incidence of overall POPF (Biochemical leak, grade B, and C) Incidence of POPF by each suturing method to approximate the pancreas and the jejunum Incidence of delayed gastric emptying (DGE) Incidence of intraabdominal abscess Incidence of postpancreatectomy hemorrhage (PPH) Incidence of interventional drainage Incidence of overall postoperative complications Incidence of POPF-related complications (POPF+DGE+abscess+PPH) Incidence of 3-month mortality Incidence of reoperation Incidence of readmission | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactIsaku Yoshioka
Faculty of Medicine, Academic Assembly, University of Toyama Department of Surgery and Science
Outcome results
None listed