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New Introducer PEG-Gastropexy Does Not Need Prophylactic Antibiotics: Prospective Randomised Double Blind Placebo Controlled Trial

16 Years
88 Years
Not Enrolling
Head and Neck Neoplasms, Wound Infection

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Trial Information

New Introducer PEG-Gastropexy Does Not Need Prophylactic Antibiotics: Prospective Randomised Double Blind Placebo Controlled Trial

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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

peristomal infection rate over a period of 7 days after PEG-gastropexy

Outcome Time Frame:

cross sectional

Principal Investigator

Yogesh M Shastri, MD, DNB

Investigator Role:

Principal Investigator

Investigator Affiliation:

JW Goethe University Hospital, Frankfurt


Germany: "Fachbereich Medizin der der JW Goethe Universit├Ąt Frankfurt am Main"

Study ID:




Start Date:

October 2003

Completion Date:

April 2007

Related Keywords:

  • Head and Neck Neoplasms
  • Wound Infection
  • Enteral tube feeding,
  • endoscopic gastropexy,
  • percutaneous endoscopic gastrostomy,
  • PEG
  • Neoplasms
  • Head and Neck Neoplasms
  • Wound Infection