Head and Neck NeoplasmsNCT00375414
Role of Prophylactic Antibiotics in New Introducer PEG-Gastropexy
A study testing PEG-Gastropexy in people with Head and Neck Neoplasms and Wound Infection, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
Peristomal infections are the commonest complications of PEG despite prophylactic antibiotics which may result in emergence of resistant micro-organisms like Methicillin resistant Staphylococcus aureus (MRSA). Read more about this study
- Who is it for?
- Ages 16 to 88 years
- Conditions the study is for
- Head and Neck Neoplasms, Wound Infection
- What is being tested?
- PEG-Gastropexy
- Type of treatment
- Surgery or procedure
- How many people
- 97 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2003to Apr 2007
- 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 16 to 88 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients having very tight stenotic malignant lesions of the upper GI tract (i.e. esophagus and or oropharynx) in whom routine pull PEG is not possible without dilatation/bougeinage of the UGI tract. The GI lumen in patients included in this study would have just sufficiently enough diameters to allow only the passage of thin (8.8 mm) endoscope.
Who cannot join
- Allergies to Ceftriaxone antibiotics,
- Patients receiving systemic antibiotics,
- Any contraindications to PEG like, severe coagulation disorders, peritonitis, peritoneal carcinomatosis, burns or inability to achieve transillumination.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Medicine I, Division of Gastroenterology and Clinical Nutrition, Johann Wolfgang Goethe-University Hospital,
Frankfurt am Main, D60590
About this study
Official title: New Introducer PEG-Gastropexy Does Not Need Prophylactic Antibiotics: Prospective Randomised Double Blind Placebo Controlled Trial
Peristomal infections are the commonest complications of PEG despite prophylactic antibiotics which may result in emergence of resistant micro-organisms like Methicillin resistant Staphylococcus aureus (MRSA). Introducer PEG technique avoids the sojourn of PEG catheter through the oropharynx so chances of infectious complications are negligible. It was not popular because of associated risks and complications. However the new introducer PEG gastropexy has been recently proved to be safe. To determine the incidence of peristomal wound infections during the immediate 7 day post procedure follow up period after the new introducer PEG gastropexy
Read the detailed description
BACKGROUND:PEG can be performed by pull, push or introducer technique, pull method is the one most commonly used worldwide. PEG site infection is clearly the commonest procedure related complication of PEG placement and the routinely used pull technique has been shown to have quite high (4-30%), peristomal infectious complications. To curtail these infectious complications various gastroenterological societies have recommended giving intravenous prophylactic antibiotics 30 minutes prior to the procedure which has been shown to significantly reduce this complication. Despite this the incidence of peristomal infectious complications remains high post PEG. Another problem associated with the administration of prophylactic antibiotics is the emergence of resistant micro-organisms especially the Methicillin resistant Staphylococcus aureus (MRSA) at the PEG site. Introducer PEG is the technique of PEG placement which avoids the transit of PEG catheter through the oropharynx. Despite its introduction since 19 years back it has not become popular among endoscopists because of technical difficulties and complications associated with it. However the newer introducer PEG technique using endoscopic gastropexy has been shown to be quite safe and easy to perform in recent studies. We at our institute have been performing this procedure since January 2003 and on prospective follow up have found much lower incidence of peristomal infections with it. Recently Maetani et al have already demonstrated in a prospective randomised trial that the introducer type PEG results in fewer infectious complications as compared to conventional pull PEG. There is no study comparing introducer PEG technique with or without administration of prophylactic antibiotics. As in principal, the chances of infections are much lower in the introducer technique. We want to address this issue in a randomised double blind placebo controlled settings in those patients who will as it is unfit to undergo routine pull PEG because of upper gastrointestinal (UGI) malignant stenoses.
SUMMARY: Peristomal infections are the commonest complications of PEG despite prophylactic antibiotics which may result in emergence of resistant micro-organisms like Methicillin resistant Staphylococcus aureus (MRSA). Introducer PEG technique avoids the travel of PEG catheter through the oropharynx which is richly inhabitated with microorganisms so chances of infectious complications at the raw PEG wound are negligible. This technique was not popular because of associated risks and complications in the past which has shown it to result in complications like deflation of balloons, catheter dislodgement, leading to peritonitis etc. However the new introducer PEG gastropexy has been recently proved to be safe. At our institute about 200 PEG procedures are performed annually, out of these 10-12% have tight stenotic stricture in which pull PEG is not possible without dilatation of oropharyngeal tract. We plan to randomise these patients in to 2 groups with and without antibiotics (placebo). PEG will be done using the new introducer PEG, Freka® Pexact CH/FR 15 (Fresenius Kabi, Germany), in which the gastric wall is sutured non surgically to the anterior abdominal wall using 2 silk sutures. Peristomal wound would be assessed daily for 7 days using 2 types of point scores systems (given by Jain and by Gossner) by 2 members of nutrition support team independently. As these are the objective scoring systems, we intend to determine the grades of post procedure peristomal infections in these patients.
- Conditions
- Head and Neck Neoplasms, Wound Infection
- Being tested
- PEG-Gastropexy
- Keywords
- Enteral tube feeding,, endoscopic gastropexy,, percutaneous endoscopic gastrostomy,, PEG
- Medical subject headings
- Head and Neck Neoplasms, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-GastropexyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
peristomal infection rate over a period of 7 days after PEG-gastropexy
Measured: cross sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2006 (estimated)
- Study startOct 2003
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bethanien Krankenhaus gGmbH
- Investigators
- Yogesh M Shastri, MD, DNB, Principal investigator, JW Goethe University Hospital, Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375414
- Sponsor's protocol ID
- Gastropexy
- Status last verified
- May 2007
- First submitted
- 12 Sep 2006
- Last updated
- 7 May 2007
- Results posted
- No
Publications
Shastri YM, Hoepffner N, Tessmer A, Ackermann H, Schroeder O, Stein J. New introducer PEG gastropexy does not require prophylactic antibiotics: multicenter prospective randomized double-blind placebo-controlled study. Gastrointest Endosc. 2008 Apr;67(4):620-8. doi: 10.1016/j.gie.2007.10.044.
PubMed 18374024
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Introducer PEG-Gastropexy Does Not Need Prophylactic Antibiotics: Prospective Randomised Double Blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT00375414
- Acronym / sponsor ID
- Gastropexy
- Conditions
- Head and Neck Neoplasms, Wound Infection
- Keywords
- Enteral tube feeding,, endoscopic gastropexy,, percutaneous endoscopic gastrostomy,, PEG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Collaborators
- Bethanien Krankenhaus gGmbH
- Study start
- Oct 2003
- Study completion
- Apr 2007 (actual)
- First posted
- 13 Sep 2006 (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.
Peristomal infections are the commonest complications of PEG despite prophylactic antibiotics which may result in emergence of resistant micro-organisms like Methicillin resistant Staphylococcus aureus (MRSA). Introducer PEG technique avoids the sojourn of PEG catheter through the oropharynx so chances of infectious complications are negligible. It was not popular because of associated risks and complications. However the new introducer PEG gastropexy has been recently proved to be safe. To determine the incidence of peristomal wound infections during the immediate 7 day post procedure follow up period after the new introducer PEG gastropexy
Detailed description
BACKGROUND:PEG can be performed by pull, push or introducer technique, pull method is the one most commonly used worldwide. PEG site infection is clearly the commonest procedure related complication of PEG placement and the routinely used pull technique has been shown to have quite high (4-30%), peristomal infectious complications. To curtail these infectious complications various gastroenterological societies have recommended giving intravenous prophylactic antibiotics 30 minutes prior to the procedure which has been shown to significantly reduce this complication. Despite this the incidence of peristomal infectious complications remains high post PEG. Another problem associated with the administration of prophylactic antibiotics is the emergence of resistant micro-organisms especially the Methicillin resistant Staphylococcus aureus (MRSA) at the PEG site. Introducer PEG is the technique of PEG placement which avoids the transit of PEG catheter through the oropharynx. Despite its introduction since 19 years back it has not become popular among endoscopists because of technical difficulties and complications associated with it. However the newer introducer PEG technique using endoscopic gastropexy has been shown to be quite safe and easy to perform in recent studies. We at our institute have been performing this procedure since January 2003 and on prospective follow up have found much lower incidence of peristomal infections with it. Recently Maetani et al have already demonstrated in a prospective randomised trial that the introducer type PEG results in fewer infectious complications as compared to conventional pull PEG. There is no study comparing introducer PEG technique with or without administration of prophylactic antibiotics. As in principal, the chances of infections are much lower in the introducer technique. We want to address this issue in a randomised double blind placebo controlled settings in those patients who will as it is unfit to undergo routine pull PEG because of upper gastrointestinal (UGI) malignant stenoses.
SUMMARY: Peristomal infections are the commonest complications of PEG despite prophylactic antibiotics which may result in emergence of resistant micro-organisms like Methicillin resistant Staphylococcus aureus (MRSA). Introducer PEG technique avoids the travel of PEG catheter through the oropharynx which is richly inhabitated with microorganisms so chances of infectious complications at the raw PEG wound are negligible. This technique was not popular because of associated risks and complications in the past which has shown it to result in complications like deflation of balloons, catheter dislodgement, leading to peritonitis etc. However the new introducer PEG gastropexy has been recently proved to be safe. At our institute about 200 PEG procedures are performed annually, out of these 10-12% have tight stenotic stricture in which pull PEG is not possible without dilatation of oropharyngeal tract. We plan to randomise these patients in to 2 groups with and without antibiotics (placebo). PEG will be done using the new introducer PEG, Freka® Pexact CH/FR 15 (Fresenius Kabi, Germany), in which the gastric wall is sutured non surgically to the anterior abdominal wall using 2 silk sutures. Peristomal wound would be assessed daily for 7 days using 2 types of point scores systems (given by Jain and by Gossner) by 2 members of nutrition support team independently. As these are the objective scoring systems, we intend to determine the grades of post procedure peristomal infections in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 16 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients having very tight stenotic malignant lesions of the upper GI tract (i.e. esophagus and or oropharynx) in whom routine pull PEG is not possible without dilatation/bougeinage of the UGI tract. The GI lumen in patients included in this study would have just sufficiently enough diameters to allow only the passage of thin (8.8 mm) endoscope.
Key exclusion criteria (3 listed)
- Allergies to Ceftriaxone antibiotics,
- Patients receiving systemic antibiotics,
- Any contraindications to PEG like, severe coagulation disorders, peritonitis, peritoneal carcinomatosis, burns or inability to achieve transillumination.
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 |
|---|---|---|
| PEG-Gastropexy | Procedure or surgery | – |
Primary outcome
peristomal infection rate over a period of 7 days after PEG-gastropexy
Time frame: cross sectional
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2007.
- Derived from this study: PubMed 18374024Shastri YM, Hoepffner N, Tessmer A, Ackermann H, Schroeder O, Stein J. New introducer PEG gastropexy does not require prophylactic antibiotics: multicenter prospective randomized double-blind placebo-controlled study. Gastrointest Endosc. 2008 Apr;67(4):620-8. doi: 10.1016/j.gie.2007.10.044.
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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.
Yogesh M Shastri, MD, DNB principal investigator
JW Goethe University Hospital, Frankfurt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEG-Gastropexy in people with Head and Neck Neoplasms and Wound Infection, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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 3 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 7 May 2007. 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 Germany. 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?
peristomal infection rate over a period of 7 days after PEG-gastropexy (time frame: cross sectional). 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 NCT00375414, which also lists 1 linked publication.
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 7 May 2007.