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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
206

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda USL Reggio Emilia - IRCCS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2011

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2011

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

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  • 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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