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

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ClinicalTrials.gov Identifier: NCT00733434
Recruitment Status : Unknown
Verified October 2009 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : August 13, 2008
Last Update Posted : October 27, 2009
Sponsor:
Information provided by:

Study Description
Brief 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.

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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 242 participants
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
Study Start Date : July 2008
Estimated Primary Completion Date : July 2009
Estimated Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Alprostadil
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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

Eligibility Criteria

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 Posted: August 13, 2008    Key Record Dates
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