Gastrostomy Tube Placed After Gastropexy Versus Gastrostomy Tube Placed Using the Traditional Push/Pull Techniques

June 20, 2025 updated by: Azienda USL Reggio Emilia - IRCCS

A Multicentric, Randomised Clinical Trial Comparing Short and Long Time Outcome of Gastrostomy Tube Placed After Gastropexy, Versus Gastrostomy Tube Placed Using the Traditional Push/Pull Techniques

Endoscopic placement of a percutaneous gastrostomy tube is a safe, efficient and well standardized technique. Two variants of this maneuver - the pull and the push techniques - are widespread worldwide. More recently different techniques, that allow the direct insertion of a gastrostomy tube has been described. The common characteristic shared by all these technique is the fact that the gastrostomy tube is inserted directly into the stomach (without passing through the pharynx), after the gastric and abdominal wall have been securely fasten together (gastropexy).

Advantage of direct techniques are the followings:

  1. the tube can placed also in the case of an oesophageal stenosis
  2. studies suggest that the peristomal wound infection are less frequent using direct techniques
  3. in some variants of these techniques, a balloon type gastrostomy tube or a button can be placed also in the case of first positioning. Both the balloon type tube and the button are easy to be changed also at the bed-side.

Drawbacks of the direct techniques are:

  1. these technique are easy, but a little more cumbersome than classic push or pull maneuvers
  2. operators are often not familiar with direct insertion
  3. kits suited for direct insertion are generally more costly than available kits for push or pull placement of gastrostomy tube.

The kit manufactured by the Kimberly-Clark (MIC Introducer kit) allows direct insertion of a balloon type gastrostomy tube or of a button and it is interesting, because it makes simple to perform the gastropexy.

The study aim is to confirm that the use of the Kit Introducer MIC, may allow safe placement of a gastrostomy tube and may reduce the incidence of peristomal wound infection. Furthermore if a balloon type gastrostomy tube or a button are positioned, they may be changed at the bed-side, without referral of the patient to the endoscopic unit or to an other sanitary facility.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

206

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MO
      • Modena, MO, Italy, 41125
        • Digestive Endoscopy Unit - Nuovo Ospedale Estense
    • RE
      • Reggio Emilia, RE, Italy, 42125
        • Gastroenterology and Digestive Endoscopy Unit - Arcispedale Santa Maria Nuova
      • Scandiano, RE, Italy, 42019
        • Endoscopic Unit "South Area" - AUSL Reggio Emilia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • all consecutive patients, candidates to percutaneous endoscopic gastrostomy placement for any common clinical indication, in the centres participating to the study.

Exclusion Criteria:

  • age < 18
  • age > 85 years old
  • pregnancy
  • coagulation deficit or anti-coagulant oral therapy
  • total gastrectomy
  • absence of trans-illumination, verified during esophagogastroduodenoscopy
  • pharyngeal or esophageal stenosis, not allowing the passage of a standard scope;
  • ascitis
  • active gastric ulcer
  • the patient or his tutor do not consent to the study
  • documented allergy to penicillin
  • ASA V.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Push/pull endoscopic gastrostomy
Device: A 20 Fr gastrostomy tube, placed using push/pull techniques.
In this group a 20 Fr gastrostomy tube will be placed, of the type in use at each centre, using the push or the pull method. Positioning of the gastrostomy tube will be carried out endoscopically in sedated patients, after antibiotic prophylaxis. Single dose ampicillin/sulbactam 1g/500 mg will be infused intravenously 30 minutes before positioning. In patients just receiving antibiotic therapy, as treatment of concomitant disease, the current therapy will be continued and antibiotic prophylaxis with ampicillin/sulbactam will be not given.
Experimental: Gastrostomy after gastropexy
Device: A 20 Fr balloon type tube, placed after gastropexy.
In this group a 20 Fr balloon type gastrostomy tube will be placed endoscopically, after gastropexy performed using the Kimberly Clarke MIC Introducer kit, according to the instructions suggested by the manufacturer. The kit includes 4 T-fasteners (only 3 are usually placed in clinical use) and a serial 24 Fr dilator with a pell-away sheath. All commercially available brands of balloon type gastrostomy tubes will be allowed for use in the study. Positioning of the gastrostomy tube will be carried out in sedated patients, after antibiotic prophylaxis (Single dose ampicillin/sulbactam 1g/500 mg ev.). In patients just receiving antibiotic therapy, as treatment of concomitant disease, the current therapy will be continued and antibiotic prophylaxis will be not given.
Other Names:
  • Kimberly Clark MIC Introducer Kit Product CODE 98423.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with peristomal wound infection.
Time Frame: From the date of randomization up to 30 days, or until the date of death from any cause, whichever came first.
Peristomal wound infection is defined as Jain score > 8, or presence of purulent exudates.
From the date of randomization up to 30 days, or until the date of death from any cause, whichever came first.
Number of patients with major complication.
Time Frame: From the date of randomization up to 30 days, or until the date of death from any cause, whichever came first.
Major complications include: 1. perforation/peritonitis or hemoperitoneum, requiring surgery; 2. Clinically relevant gastrointestinal bleeding (loss of more than 2g Hb during 24 hours and/or requiring transfusion and/or endoscopic or surgical treatment); 3. aspiration pneumonia; 4. Burried bumper syndrome.
From the date of randomization up to 30 days, or until the date of death from any cause, whichever came first.
Number of failures of positioning the gastrostomy tube.
Time Frame: From the start until the end of the endoscopic procedure.
Gastrostomy tube positioning will be performed immediately after randomization.Patients will be randomised by the endoscopist, during EGD. Only one attempt of positioning the gastrostomy tube will be allowed. Further attempts of positioning a gastrostomy tube after a failure will be not relevant to the pourpose of the study. Failures do not include patients with uncorrect positioning of the tube, if the misplacement is diagnosed after the end of the endoscopic procedure.
From the start until the end of the endoscopic procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Jain's score.
Time Frame: Jain score will be measured at follow up visits during the first month after positioning of the gastrostomy tube (on 7th, 15th, 30th days).
Jain's score is a validated scoring system, proposed to evaluate peristomal infection.
Jain score will be measured at follow up visits during the first month after positioning of the gastrostomy tube (on 7th, 15th, 30th days).
Number of gastrostomy tube substitutions for each patient.
Time Frame: From date of randomization until the date of definitive removal of the tube or date of death from any cause, whichever came first, assessed up to 13 months.
The setting of the substitution will be recorded (at bed site, endoscopic unit, other sanitary facilities).
From date of randomization until the date of definitive removal of the tube or date of death from any cause, whichever came first, assessed up to 13 months.
Number of episodes of referral to the hospital or to any sanitary facility (outpatient clinic visit included), due to gastrostomy tube.
Time Frame: From date of randomization until the date of definitive removal of the tube or date of death from any cause, whichever came first, assessed up to 13 months
From date of randomization until the date of definitive removal of the tube or date of death from any cause, whichever came first, assessed up to 13 months
Days of antibiotic therapy after gastrostomy tube positioning.
Time Frame: From the date of randomization up to 30 days, or until the date of death from any cause, whichever came first.
From the date of randomization up to 30 days, or until the date of death from any cause, whichever came first.
Mean time required for tube positioning, as measured in minutes.
Time Frame: From the start until the end of the endoscopic procedure.
From the start until the end of the endoscopic procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda USL Reggio Emilia - IRCCS

Investigators

  • Study Chair: Vincenzo Mirante, MD, Nuovo Ospedale Estense - AUSL Modena
  • Study Chair: Angela Mazzocchi, MD, Artificial Nutrition Interdisciplinary Team - AUSL Reggio Emilia
  • Study Chair: Fabio Fabbian, MD, Endoscopy Unit - AUSL RE
  • Study Chair: Rita Conigliaro, MD, Nuovo Ospedale Estense - AUSL Modena
  • Study Chair: Romano Sassatelli, MD, Azienda USL Reggio Emilia - IRCCS
  • Principal Investigator: Lorenzo Camellini, MD, Azienda USL Reggio Emilia - IRCCS
  • Study Chair: Veronica Iori, MD, Azienda USL Reggio Emilia - IRCCS
  • Study Chair: Giorgio Iori, Reg. Nurse, Azienda USL Reggio Emilia - IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

October 30, 2011

First Submitted That Met QC Criteria

November 1, 2011

First Posted (Estimated)

November 2, 2011

Study Record Updates

Last Update Posted (Estimated)

June 25, 2025

Last Update Submitted That Met QC Criteria

June 20, 2025

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ASMN1PEG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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