Patients judged to be eligible for PD or DP (regardless of diseases).
Conditions
Interventions
In pancreatic resection (including laparoscopic and robot-assisted procedures), the investigational device will be thinly applied to areas where pancreatic fluid leakage is concerned (such as the panc
Sponsors
Eguchi Hidetoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria 1. Patients eligible for open or laparoscopic (including robot-assisted) PD (pancreaticoduodenectomy) with pancreatojejunostomy or DP (distal pancreatectomy). 2. Male and female aged 20 years or older at the time of informed consent. 3. Patients with an ECOG Performance Status (PS) of 0-1. 4. Patients with preserved major organ function (bone marrow, liver, kidney, lung, etc.), meeting the following criteria: (1) WBC: 2,000/mm3 1,000/mm3 (3) Hemoglobin: Hb => 9.0 g/dL (4) Platelets: PLT => 75,000/mm3 (5) T-Bil: T-Bil <= 2.0 mg/dL (6) AST: AST <= 150 IU/L (7) ALT: ALT <=150 IU/L (8) CRE: CRE <=1.5 mg/dL 5.Patients who understand the purpose of the trial and provide written informed consent based on their free will. 6. Patients willing to visit the designated medical institution on the dates specified by the principal investigator or sub-investigator. 7. Patients willing to comply with the instructions and examinations of the principal investigator or sub-investigator.
Exclusion criteria
Exclusion criteria: Exclusion criteria 1.Patients with active malignant tumors other than the indicated disease for resection in this trial. 2. Patients diagnosed with acute pancreatitis. 3. Patients scheduled to undergo gastrointestinal surgery other than PD or DP during the trial period, or those who have undergone gastrointestinal surgery within the past four weeks. 4. Patients who have participated in other trials within the past 12 weeks prior to obtaining consent or those planning to participate in other trials during this study. 5. Patients with severe comorbidities such as heart disease, pulmonary fibrosis, interstitial pneumonia. 6. Patients with a history of severe drug allergies. 7. Pregnant or lactating women, or women who may be pregnant. 8. Patients requiring resection of other organs (except for the stomach, bile duct, gallbladder, duodenum, and jejunum in PD; or the spleen and adrenal gland in DP), DP with celiac artery resection, or those requiring arterial reconstruction. 9. Patients receiving continuous systemic administration of steroid or immunosuppressive agents. 10. Patients receiving somatostatin analogs. 11.Patients taking anticoagulant medications. 12.Patients deemed unsuitable for participation in this clinical trial by the principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Adverse Event 2.Problems | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Effectiveness assessment (1) Drain discharge and serum amylase levels (2) Evaluation of postoperative pancreatic fistula by grade (according to ISGPS definition): Biochemical leak, Grade B, Grade C (3) Overall evaluation of postoperative pancreatic fistula (according to ISGPS definition): Biochemical leak, Grade B, Grade C (4) Evaluation of postoperative pancreatic fistula (according to ISGPS definition): Grade B and Grade C (5) Postoperative intraperitoneal abscess (6)Delayed gastric emptying (7) Postoperative intra-abdominal bleeding (8) Duration of drain placement (9) Rate of drain reinsertion (10) Readmission rate (11)Reoperation rate (12) Postoperative hospital stay (13)Postoperative mortality rate (14) User experience with the investigational device | — |
Contacts
Public ContactYoshito Tomimaru
The University of Osaka Hospital
Outcome results
None listed