The Effect of Application of TachoSil® in Pancreatoduodenectomy
|ClinicalTrials.gov Identifier: NCT03269955|
Recruitment Status : Unknown
Verified August 2017 by Jae Hoon Lee, Asan Medical Center.
Recruitment status was: Recruiting
First Posted : September 1, 2017
Last Update Posted : September 1, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Neoplasm Pancreatic Periampullary Cancer Pancreatic Bordeline Tumor||Drug: Fibrinogen/thrombin-coated collagen patch||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Effect of Application of Fibrinogen/Thrombin-coated Collagen Patch (TachoSil®) in Pancreaticojejunostomy for Prevention of Pancreatic Fistula After Pancreatoduodenectomy|
|Actual Study Start Date :||February 27, 2017|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||May 2018|
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
Tachosil® is cut in half and applied to the front and back of the pancreaticojejunostomy respectively, and fibrin glue is applied on it
Other Name: TachoSil®
No Intervention: control
Only fibrin glue alone is applied to the pancreas anastomosis site in pancreaticoduodenectomy.
- Incidence of pancreatic fistula [ Time Frame: 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 [ Time Frame: 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.
- Incidence of complication except for pancreatic fistula [ Time Frame: 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.
- Removal time of drainage [ Time Frame: 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.
- Death [ Time Frame: 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.
- Re-admission rate [ Time Frame: 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.
- Period of hospitalization after surgery [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03269955
|Contact: Jaehoon Lee, Ph.Demail@example.com|
|Contact: Sookyung Leefirstname.lastname@example.org|
|Korea, Republic of|
|Asan Medical Center||Recruiting|
|Seoul, Songpagu, Korea, Republic of, 05505|
|Contact: Jaehoon Lee, Ph.D +82-2-3010-1521 email@example.com|
|Principal Investigator:||Jaehoon Lee, Ph.D||Asan Medical Center|