MicrosurgeryPhase 4PGE1HNMNCT00733434
The Use of Prostaglandin E1 in Head and Neck Microsurgery
A Phase 4 study testing Prostaglandin E1 and Saline in people with Microsurgery and Head and Neck, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Microsurgery, Head and Neck, Prostaglandin E1
- What is being tested?
- Prostaglandin E1 and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 242 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2008to Jul 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring microvascular reconstruction after head and neck cancer resection
Who cannot join
- Patients with coagulation dysfunction
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National taiwan University Hospital
Taipei, 100
Yueh-Bih Tang, MD, PhD, 886-2-23123456 ext. 5107, phoebetang@ntu.edu.tw
Yueh-Bih Tang, MD, PhD
About this study
Official title: Phase 4 Study of Postoperative Prostaglandin E1 in Head and Neck Microsurgery
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.
Read the 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.
- Conditions
- Microsurgery, Head and Neck, Prostaglandin E1, Thrombosis, Complications
- Being tested
- Prostaglandin E1, Saline
- Keywords
- Microsurgery, Head and neck, Prostaglandin E1, Thrombosis, Complication
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostaglandin E1Drug
Also called Alprostadil, Promostan
PGE 1 80mcg/500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days
SalineOther
Also called Normal saline
500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients receiving PGE 1 80mcg/500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days Receives: Drug: Prostaglandin E1 |
| 2 | Placebo comparator | Patients receiving 500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free flap re-exploration rate
Measured: 7 days after microsurgery
Secondary outcomes (1)
Surgical complication rate
Measured: hospitalization period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionJul 2009 (estimated)
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for MicrosurgeryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yueh-Bih Tang, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00733434
- Sponsor's protocol ID
- 200707036R
- Acronym
- PGE1HNM
- Status last verified
- Oct 2009
- First submitted
- 12 Aug 2008
- Last updated
- 27 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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. doi: 10.1097/01.PRS.0000083378.58757.54.
PubMed 14578781Rodriguez Vegas JM, Ruiz Alonso ME, Teran Saavedra PP. PGE-1 in replantation and free tissue transfer: early preliminary experience. Microsurgery. 2007;27(5):395-7. doi: 10.1002/micr.20377.
PubMed 17596843Ashjian 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. doi: 10.1097/01.sap.0000264837.15110.2f.
PubMed 17589257Watanabe 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. doi: 10.1378/chest.123.3.952.
PubMed 12628901Barthelmes 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. doi: 10.1038/sj.ijir.3900853.
PubMed 12058249Lee 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. doi: 10.1142/s0218810401000643.
PubMed 11901464
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Postoperative Prostaglandin E1 in Head and Neck Microsurgery
- ClinicalTrials.gov ID
- NCT00733434
- Acronym / sponsor ID
- PGE1HNM / 200707036R
- Conditions
- Microsurgery, Head and Neck, Prostaglandin E1, Thrombosis, Complications
- Keywords
- Microsurgery, Head and neck, Prostaglandin E1, Thrombosis, Complication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 13 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Prostaglandin E1Patients receiving PGE 1 80mcg/500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days |
| 2 | Placebo comparator | Other: SalinePatients receiving 500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients requiring microvascular reconstruction after head and neck cancer resection
Key exclusion criteria (1 listed)
- Patients with coagulation dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostaglandin E1Also: Alprostadil, PromostanPGE 1 80mcg/500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days | Drug | 1 |
| SalineAlso: Normal saline500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days | Other | 2 |
Primary outcome
Free flap re-exploration rate
Time frame: 7 days after microsurgery
1 secondary outcome
Surgical complication rate
Time frame: hospitalization period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2009.
- Background: PubMed 14578781Disa 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. doi: 10.1097/01.PRS.0000083378.58757.54.
- Background: PubMed 17596843Rodriguez Vegas JM, Ruiz Alonso ME, Teran Saavedra PP. PGE-1 in replantation and free tissue transfer: early preliminary experience. Microsurgery. 2007;27(5):395-7. doi: 10.1002/micr.20377.
- Background: PubMed 17589257Ashjian 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. doi: 10.1097/01.sap.0000264837.15110.2f.
- Background: PubMed 12628901Watanabe 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. doi: 10.1378/chest.123.3.952.
- Background: PubMed 12058249Barthelmes 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. doi: 10.1038/sj.ijir.3900853.
- Background: PubMed 11901464Lee 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. doi: 10.1142/s0218810401000643.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yueh-Bih Tang, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prostaglandin E1 and Saline in people with Microsurgery and Head and Neck, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yueh-Bih Tang, MD, PhD (886-2-23123456 ext. 5107, phoebetang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Free flap re-exploration rate (time frame: 7 days after microsurgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00733434, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2009.