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2017-02-27
2018-05
2018-05
126
NCT03269955
Asan Medical Center
Asan Medical Center
INTERVENTIONAL
The Effect of Application of TachoSil® in Pancreatoduodenectomy
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2017-08-23 | N/A | 2017-08-30 |
2017-08-30 | N/A | 2017-09-01 |
2017-09-01 | N/A | 2017-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Prevention
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: application of TachoSil® Fibrinogen/thrombin-coated collagen patch (TachoSil®) and fibrin glue are applied to the pancreas anastomosis site in pancreatoduodenectomy | DRUG: Fibrinogen/thrombin-coated collagen patch
|
| NO_INTERVENTION: control Only fibrin glue alone is applied to the pancreas anastomosis site in pancreaticoduodenectomy. |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Incidence of pancreatic fistula | 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. | At 3 days after surgery |
| Incidence of clinically relevant pancreatic fistula | 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. | At 5 days after surgery |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Incidence of complication except for pancreatic fistula | 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. | Through study completion, an average of 1 year |
| Removal time of drainage | 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. | 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 |
| Death | 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. | From date of surgery to 30 days after discharge |
| Re-admission rate | Includes all cases of re-admission after discharge due to problems associated with pancreatoduodenectomy. Except for cases not related to pancreaticoduodenectomy. | Through study completion, an average of 1 year |
| Period of hospitalization after surgery | The duration of the hospital stay is calculated based on the time when the actual patient is discharged. | From date of surgery until the date of discharge, whichever came first, assessed up to study completion, an average of 1 year |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Jaehoon Lee, Ph.D Phone Number: +82-2-3010-1521 Email: hbpsurgeon@gmail.com |
Study Contact Backup Name: Sookyung Lee Phone Number: +82-2-3010-6921 Email: goggle44@naver.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
19 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
