임상연구정보서비스

Search: Search

The effect of intraoperative botulinum toxin injection in parotidectomy

Status Approved

First Submitted Date

2019/09/30
Registered Date

2019/11/19
Last Updated Date

2019/09/30

Move list page

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0004450
Unique Protocol ID	D-1708-001-067
Public/Brief Title	Intraoperative Botulinum Toxin Injection in Parotidectomy
Scientific Title	The effect of intraoperative botulinum toxin injection in parotidectomy
Acronym	IBOTIP
MFDS Regulated Study	Yes
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	D-1708-001-067
Approval Date	2017-08-02
Institutional Review Board Name	the Institutional Review Board (IRB) of Pusan National University Hospital
Institutional Review Board Address	179, Gudeok-ro, Seo-gu, Busan
Institutional Review Board Telephone	051-240-7529
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Wonjae Cha
Title	MD, PhD
Telephone	+82-51-240-7336
Affiliation	Pusan National University Hospital
Address	179 Gudeok-Ro, Seo-Gu, Busan, 602-739, South Korea
Contact Person for Public Queries
Name	Wonjae Cha
Title	MD, PhD
Telephone	+82-51-240-7336
Affiliation	Pusan National University Hospital
Address	179 Gudeok-Ro, Seo-Gu, Busan, 602-739, South Korea
Contact Person for Updating Information
Name	Wonjae Cha
Title	MD, PhD
Telephone	+82-51-240-7336
Affiliation	Pusan National University Hospital
Address	179 Gudeok-Ro, Seo-Gu, Busan, 602-739, South Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2017-08-07 Actual
Target Number of Participant	60
Primary Completion Date	2019-04-02 , Actual
Study Completion Date	2019-06-30 , Actual
Name of Study	Pusan National University Hospital
Recruitment Status	Completed
Date of First Enrollment	2017-08-07 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Pusan National University Hospital
Organization Type	Medical Institute
Project ID	2018B028

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Pusan National University Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Parotidectomy is the mainstay for the treatment of parotid tumors. Although it is known for effective and safe surgery, many complications can perioperatively. The most important complications are facial nerve palsy, Frey syndrome, sialocele, and salivary fistula. Except for facial nerve palsy and Frey syndrome, sialocele/salivary fistula is due to continuous leakage of saliva from parotid parenchyma. Usually limiting diets, but despite restriction of the diet to increase saliva production, there are many reported cased of postoperative sialocele/ salivary fistula. Recently, botulinum toxin has been reported to reduce saliva secretion. Also, the use of botulinum toxin injection under ultrasonographic guidance was reported for therapeutic purposes in sialocele/salivary fistula that occurred after surgery. However, once these complications related to saliva occurs, repeated treatment, long treatment periods, and re-admission are sometimes required. Therefore, the prevention of saliva problems is also important as well as postoperative treatments. In this study, botulinum toxin injection is intraoperatively administered to prevent postoperative sialocele/salivary fistula and its safety and efficacy are evaluated.

Study Summary Information

Lay Summary

Parotidectomy is the mainstay for the treatment of parotid tumors. Although it is known for effective and safe surgery, many complications can perioperatively. The most important complications are facial nerve palsy, Frey syndrome, sialocele, and salivary fistula. Except for facial nerve palsy and Frey syndrome, sialocele/salivary fistula is due to continuous leakage of saliva from parotid parenchyma. Usually limiting diets, but despite restriction of the diet to increase saliva production, there are many reported cased of postoperative sialocele/ salivary fistula. Recently, botulinum toxin has been reported to reduce saliva secretion. Also, the use of botulinum toxin injection under ultrasonographic guidance was reported for therapeutic purposes in sialocele/salivary fistula that occurred after surgery. However, once these complications related to saliva occurs, repeated treatment, long treatment periods, and re-admission are sometimes required. Therefore, the prevention of saliva problems is also important as well as postoperative treatments. In this study, botulinum toxin injection is intraoperatively administered to prevent postoperative sialocele/salivary fistula and its safety and efficacy are evaluated.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Prevention
Phase	Not applicable
Intervention Model	Single Group
Blinding/Masking	Open
Allocation	Not Applicable
Intervention Type	Drug
Intervention Description	Botulinum toxin (type A) is intraoperatively administered during partial parotidectomy to prevent sialocele/salivary fistula. Botulinum toxin (5 unit/ml) was injected at the 5 points indicated. The needle was gently inserted into the parotid parenchyma within 10mm depth to avoid the injury of the facial nerve. After the insertion of the needle, it is aspirated to prevent intravenous injection. Finally, total of 25 units of botulinum toxin were administrated for each participant.
Number of Arms	1
Arm 1	Arm Label BTX
	Target Number of Participant 60
	Arm Type Experimental
	Arm Description Botulinum toxin (type A) is intraoperatively administered during partial parotidectomy to prevent sialocele/salivary fistula. Botulinum toxin (5 unit/ml) was injected at the 5 points indicated. The needle was gently inserted into the parotid parenchyma within 10mm depth to avoid the injury of the facial nerve. After the insertion of the needle, it is aspirated to prevent intravenous injection. Finally, total of 25 units of botulinum toxin were administrated for each participant.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (C00-D48)Neoplasms (C07)Malignant neoplasm of parotid gland 보툴리늄 독소 이하선 종양 이하선 수술 타액낭 타액루 예방
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 18Year~75Year
	Description The patients who supposed to undergo partial parotidectomy for therapeutic purpose.
Exclusion Criteria	The exclusion criteria were as follows: patients who have (1) the history of botulinum toxin administration in 3 months (2) the experience of hypersensitivity or allergic reaction for botulinum toxin (3) the history of the operation for high-risk cancer (4) coagulopathies (5) the possibility of pregnancy or are breastfeeding (6) the history of spastic cerebral palsy, peripheral motor neuropathies (Amyotrophic lateral sclerosis and other motor neuron diseases) (7) the history of neuromuscular junction diseases (myasthenia gravis) and other neuromuscular diseases (8) severe respiratory failure (9) systemic lupus erythematosus (10) the needs of aminoglycoside, spectinomycin, polymyxin, tetracycline and lincomycin.
Healthy Volunteers

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	The incidence of facial nerve paralysis for safety
Timepoint	at 1 day postoperatively
Primary Outcome(s) 2
Outcome	The incidence of postoperative sialocele and salivary fistula for the efficacy.
Timepoint	at 3 months postoperatively
Secondary Outcome(s) 1
Outcome	Drainage volume during admission
Timepoint	at 2 week postoperatively
Secondary Outcome(s) 2
Outcome	Minor complication after discharge (hemorrhage/hematoma, infection, wound dehiscence, re-admission, dry mouth)
Timepoint	at 6 months postoperatively

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

Move list page Move to top