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Esophageal NeoplasmsNCT00335010

Intravenous NTG to Preserve Gastric Microcirculation During Gastric Tube Reconstruction

A study testing Nitroglycerin in people with Esophageal Neoplasms and Microcirculation, run by Erasmus Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the present study was to investigate if NTG, administered intravenously during gastric tube reconstruction, could preserve gastric fundus tissue blood flow and oxygenation and reduce the incidence of postoperative leakage. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Neoplasms, Microcirculation
What is being tested?
Nitroglycerin
How many people
32 participants
Where
1 siteNetherlands
Study dates
May 2005to Dec 2005
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Planned esophagectomy with gastric tube reconstruction
  • written informed consent
  • ASA I and II

Who cannot join

  • younger than 18

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Erasmus MC

    Rotterdam, 3000ZA

Other trials in Netherlands

About this study

Official title: A Prospective Double Blinded Study on the Effect of Intravenously Administrated Nitroglycerine on Gastric Tissue Microvascular Bloodflow and Microvascular Hemoglobin Saturation During Gastric Tube Reconstruction

The aim of the present study was to investigate if NTG, administered intravenously during gastric tube reconstruction, could preserve gastric fundus tissue blood flow and oxygenation and reduce the incidence of postoperative leakage.

Read the detailed description

Complications of oesophagectomy and gastric tube reconstruction are leakage and stenosis, which may be due to compromised microvascular blood flow (MBF) in the gastric tissue. We recently demonstrated that peri-operatively decreased MBF could be improved by topical administration of nitro-glycerine NTG). In this present study we investigate the effect of intravenous NTG on gastric microcirculation.

This single centre, prospective, double blinded study randomized thirty-two patients scheduled for esophagectomy into two groups. The intervention group received intravenous NTG during gastric tube reconstruction, as the control group received normal saline.

Baseline values of MBF, microvascular haemoglobin O2 saturation (μHbSO2), and microvascular haemoglobin concentration (μHbcon) were determined at the gastric fundus before and after gastric tube construction and after pulling up the gastric tube to the neck.

Being tested
Nitroglycerin
Keywords
Nitroglycerine, gastroesophageal anastomosis, microvascular bloodflow, microvascular hemoglobinsaturation
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NitroglycerinDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. differences in Microvascular bloodflow

  2. differences in microvascular hemoglobinsaturation

Secondary outcomes (2)

  1. differences in anastomotic leakage

  2. differences in anastomotic stenosis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2006 (estimated)
  2. Study startMay 2005
  3. Study completionDec 2005

Resources

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 N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
32 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00335010
Sponsor's protocol ID
MEC-2004-160
Status last verified
Jun 2006
First submitted
7 Jun 2006
Last updated
8 Jun 2006
Results posted
No

Publications

  • Buise MP, Ince C, Tilanus HW, Klein J, Gommers D, van Bommel J. The effect of nitroglycerin on microvascular perfusion and oxygenation during gastric tube reconstruction. Anesth Analg. 2005 Apr;100(4):1107-1111. doi: 10.1213/01.ANE.0000147665.60613.CA.

    PubMed 15781529

  • Pierie JP, de Graaf PW, van Vroonhoven TJ, Obertop H. Healing of the cervical esophagogastrostomy. J Am Coll Surg. 1999 Apr;188(4):448-54. doi: 10.1016/s1072-7515(99)00003-4. No abstract available.

    PubMed 10195730

  • Jacobi CA, Zieren HU, Zieren J, Muller JM. Is tissue oxygen tension during esophagectomy a predictor of esophagogastric anastomotic healing? J Surg Res. 1998 Feb 1;74(2):161-4. doi: 10.1006/jsre.1997.5239.

    PubMed 9587355

  • Siegemund M, van Bommel J, Ince C. Assessment of regional tissue oxygenation. Intensive Care Med. 1999 Oct;25(10):1044-60. doi: 10.1007/s001340051011. No abstract available.

    PubMed 10551958

  • Buise M, van Bommel J, Jahn A, Tran K, Tilanus H, Gommers D. Intravenous nitroglycerin does not preserve gastric microcirculation during gastric tube reconstruction: a randomized controlled trial. Crit Care. 2006;10(5):R131. doi: 10.1186/cc5043.

    PubMed 16970804

Questions about this trial

What is this clinical trial studying?

A study testing Nitroglycerin in people with Esophageal Neoplasms and Microcirculation, run by Erasmus Medical Center at 1 site in Netherlands.

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 3 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: finished, as of the sponsor's last update on 8 Jun 2006. 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 Netherlands. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

differences in Microvascular bloodflow. The study lists 2 primary outcomes in all. 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 NCT00335010, which also lists 5 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 8 Jun 2006.

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