The Use of Prostaglandin E1 in Head and Neck Microsurgery

Thrombosis Clinical Trial

— PGE1HNM  

Official title:

Phase 4 Study of Postoperative Prostaglandin E1 in Head and Neck Microsurgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00733434
• Other study ID #: 200707036R
• Status: Recruiting
• Phase: Phase 4
• First received: August 12, 2008
• Last updated: October 26, 2009
• Start date: July 2008
• Est. completion date: July 2010

Study information

• Verified date: October 2009
• Source: National Taiwan University Hospital
• Contact: Yueh-Bih Tang, MD, PhD
• Phone: 886-2-23123456
• Email: phoebetang[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

Prostaglandin E1 (PGE1 )has been shown to have vasodilatation and anti-thrombosis effects, so it is used by some surgeons after microsurgery to keep the patency of the anastomosed small vessels. However, PGE 1 may also causes some complications, like pleural effusion or deep vein thrombosis. Therefore, it remains uncertain whether a routine use of PGE 1 after head and neck microsurgery is justified. We aim to test the hypothesis that PGE 1 increases postoperative vessel patency rate in patients undergoing head and neck microsurgery, with a comparable complication rate as the control group.

Description:

Despite meticulous microsurgical techniques, free flap failure due to postoperative vessel thrombosis cannot be completely eliminated. Postoperative pharmacological augmentation of the established blood flow is considered as a feasible solution to this problem. Prostaglandin E1 (PGE1 )has been shown to have vasodilatation and anti-thrombosis effects, so it is used by some surgeons after microsurgery to keep the patency of the anastomosed small vessels. However, PGE 1 may also causes some complications, like pleural effusion or deep vein thrombosis. Therefore, it remains uncertain whether a routine use of PGE 1 in every patient after head and neck microsurgery is justified. We aim to test the hypothesis that PGE 1 increases postoperative vessel patency rate in patients undergoing head and neck microsurgery, and yielded a comparable complication rate as the control group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 242
• Est. completion date: July 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients requiring microvascular reconstruction after head and neck cancer resection

Exclusion Criteria:

• Patients with coagulation dysfunction

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complications
• Head and Neck
• Microsurgery
• Prostaglandin E1
• Thrombosis

Intervention

Drug:
• Prostaglandin E1
PGE 1 80mcg/500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days

Other:
• Saline
500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days

Locations

Country	Name	City	State
Taiwan	National taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (6)

Ashjian P, Chen CM, Pusic A, Disa JJ, Cordeiro PG, Mehrara BJ. The effect of postoperative anticoagulation on microvascular thrombosis. Ann Plast Surg. 2007 Jul;59(1):36-9; discussion 39-40. — View Citation

Barthelmes L, Chezhian C, Aihaku EK. Deep venous thrombosis and venous thrombophlebitis associated with alprostadil treatment for erectile dysfunction. Int J Impot Res. 2002 Jun;14(3):199-200. Review. — View Citation

Disa JJ, Polvora VP, Pusic AL, Singh B, Cordeiro PG. Dextran-related complications in head and neck microsurgery: do the benefits outweigh the risks? A prospective randomized analysis. Plast Reconstr Surg. 2003 Nov;112(6):1534-9. — View Citation

Lee KS, Suh JD, Han SB, Yoo JC, Lee SJ, Cho SJ. The effect of aspirin and prostaglandin E(1) on the patency of microvascular anastomosis in the rats. Hand Surg. 2001 Dec;6(2):177-85. — View Citation

Rodríguez Vegas JM, Ruiz Alonso ME, Terán Saavedra PP. PGE-1 in replantation and free tissue transfer: early preliminary experience. Microsurgery. 2007;27(5):395-7. — View Citation

Watanabe H, Anayama S, Horiuchi T, Sato E, Hamada Y, Ishihara H. Pleural effusion caused by prostaglandin E1 preparation. Chest. 2003 Mar;123(3):952-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Free flap re-exploration rate		7 days after microsurgery	No
Secondary	Surgical complication rate		hospitalization period	Yes