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The Use of Prostaglandin E1 in Head and Neck Microsurgery (PGE1HNM)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00733434
First Posted: August 13, 2008
Last Update Posted: October 27, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Taiwan University Hospital
  Purpose
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.

Condition Intervention Phase
Microsurgery Head and Neck Prostaglandin E1 Thrombosis Complications Drug: Prostaglandin E1 Other: Saline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Postoperative Prostaglandin E1 in Head and Neck Microsurgery

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Free flap re-exploration rate [ Time Frame: 7 days after microsurgery ]

Secondary Outcome Measures:
  • Surgical complication rate [ Time Frame: hospitalization period ]

Estimated Enrollment: 242
Study Start Date: July 2008
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients receiving PGE 1 80mcg/500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days
Drug: Prostaglandin E1
PGE 1 80mcg/500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days
Other Name: Alprostadil, Promostan
Placebo Comparator: 2
Patients receiving 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
Other Name: Normal saline

Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients requiring microvascular reconstruction after head and neck cancer resection

Exclusion Criteria:

  • Patients with coagulation dysfunction
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00733434


Contacts
Contact: Yueh-Bih Tang, MD, PhD 886-2-23123456 ext 5107 phoebetang@ntu.edu.tw

Locations
Taiwan
National taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Yueh-Bih Tang, MD, PhD    886-2-23123456 ext 5107    phoebetang@ntu.edu.tw   
Principal Investigator: Yueh-Bih Tang, MD, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Yueh-Bih Tang, MD, PhD National Taiwan University Hospital
  More Information

Publications:
Responsible Party: Yueh-Bih Tang, Professor of Surgery, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00733434     History of Changes
Other Study ID Numbers: 200707036R
First Submitted: August 12, 2008
First Posted: August 13, 2008
Last Update Posted: October 27, 2009
Last Verified: October 2009

Keywords provided by National Taiwan University Hospital:
Microsurgery
Head and neck
Prostaglandin E1
Thrombosis
Complication

Additional relevant MeSH terms:
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Alprostadil
Platelet Aggregation Inhibitors
Vasodilator Agents
Urological Agents