Pancreatic Bordeline Tumor, Pancreatic Neoplasm, Pancreatic Periampullary Cancer
Conditions
Brief summary
Fibrinogen/thrombin-coated collagen patch (TachoSil®) is known to have the effect of strengthening tissue anastomosis and promoting suturing to prevent leakage. The purpose of this study is to compare the incidence of pancreatic fistula that is most crucial for surgical outcome and complications in pancreaticoduodenectomy with those of the control group and the TachoSil® apply group. Patients who were planned to undergo pancreaticoduodenectomy without a history of chronic pancreatitis are enrolled in this open-label, single-center, randomized, single-blind, phase 4 clinical trial.
Interventions
DRUGFibrinogen/thrombin-coated collagen patch
Tachosil® is cut in half and applied to the front and back of the pancreaticojejunostomy respectively, and fibrin glue is applied on it
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* ECOG performance score of 0-2 * Periampulary cancer or borderline tumor that is able to resection on preoperative examination * Patients without distance metastasis * Bone marrow function: WBC at least 3,000/mm3 or absolute neutrophil count at least 1,500/mm3, Platelet count at least 125,000/mm3 * Liver function: AST/ALT less than 3 times upper limit of normal * Kidney function: Creatinine no greater than 1.5 times upper limit of normal * Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
* Patients with distant metastases are not eligible * Recurred periampulary cancer * Pregnant and breastfeeding women * Patients with active or uncontrolled infection * Patients with uncontrolled heart disease * Patients with moderate or severe comorbidities who are thought to have an impact on quality of life or nutritional status (Liver cirrhosis, chronic kidney failure, heart failure, etc.) * Patients who underwent other major abdominal organs surgery except for scheduled pancreatoduodenectomy (gastrectomy, colonic resection, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of pancreatic fistula | At 3 days after surgery | The evaluation of the pancreatic fistula was based on the international study group of pancreatic fistula (ISGPF). According to the criteria, evaluation of pancreatic fistula was evaluated by measuring the amylase level of the drain tube on the third postoperative day, and the pancreatic fistula was judged to be present when the amylase level was three times higher than the normal level of the amylase in the blood. |
| Incidence of clinically relevant pancreatic fistula | At 5 days after surgery | The grade uses ISGPF grading, while the grades B and C are clinically relevant pancreatic fistula. All patients underwent abdominal CT at 5 days postoperatively for grade evaluation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death | From date of surgery to 30 days after discharge | The results are for patients who died during hospitalization. If a patient is discharged within 30 days of discharge, the death rate is the same as during death. |
| Incidence of complication except for pancreatic fistula | Through study completion, an average of 1 year | Complications other than pancreatitis include all complications after pancreatoduodenectomy. Delayed gastric emptying and postoperative bleeding complied with the criteria of the International Study Group, and the severity of complications is classified through the Clavien-Dindo classification. |
| Period of hospitalization after surgery | From date of surgery until the date of discharge, whichever came first, assessed up to study completion, an average of 1 year | The duration of the hospital stay is calculated based on the time when the actual patient is discharged. |
| Re-admission rate | Through study completion, an average of 1 year | Includes all cases of re-admission after discharge due to problems associated with pancreatoduodenectomy. Except for cases not related to pancreaticoduodenectomy. |
| Removal time of drainage | From date of surgery until the date of the last drainage removal, whichever came first, assessed up to study completion, an average of 1 year | The timing of removal of the drain tube is determined based on the time of removal of the last drain tube. The removal of the drain tube is assessed at the discretion of the surgeon. |
Countries
South Korea
Contacts
Primary ContactJaehoon Lee, Ph.D
Backup ContactSookyung Lee
Outcome results
None listed