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

This study is currently recruiting participants.
Verified August 2012 by Arcispedale Santa Maria Nuova-IRCCS
Sponsor:
Information provided by (Responsible Party):
Lorenzo Camellini, Arcispedale Santa Maria Nuova
ClinicalTrials.gov Identifier:
NCT01463540
First received: October 30, 2011
Last updated: August 15, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Gastrostomy, Methods
 Device: A 20 Fr gastrostomy tube, placed using push/pull techniques.
Device: A 20 Fr balloon type tube, placed after gastropexy.
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Arcispedale Santa Maria Nuova-IRCCS:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    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. peristomal wound infection.Peristomal wound infection is defined as Jain score > 8, or presence of purulent exudates.


Secondary Outcome Measures:
  • Number of failures of positioning the gastrostomy tube [ Time Frame: During the endoscopic procedure ] [ Designated as safety issue: Yes ]
    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.

  • 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). ] [ Designated as safety issue: Yes ]
    Jain's score is a validated scoring system, proposed to evaluate peristomal infection.

  • 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. ] [ Designated as safety issue: No ]
    The setting of the substitution will be recorded (at bed site, endoscopic unit, other sanitary facilities).

  • 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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]
  • Mean time required for tube positioning, as measured in minutes. [ Time Frame: From the start of the endoscopic procedure until the correct and complete positioning. ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Kimberly Clark MIC Introducer Kit Product CODE 98423.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463540

Locations
Italy
Digestive Endoscopy Unit - Nuovo Ospedale Estense Recruiting
Modena, MO, Italy, 41125
Contact: Vincenzo Mirante, MD         v.mirante@ausl.mo.it    
Principal Investigator: Vincenzo Mirante, MD            
Gastroenterology and Digestive Endoscopy Unit - Arcispedale Santa Maria Nuova Recruiting
Reggio Emilia, RE, Italy, 42125
Contact: Lorenzo Camellini, MD     0039 0522 296131     lorenzo.camellini@asmn.re.it    
Principal Investigator: Lorenzo Camellini, MD            
Endoscopic Unit "South Area" - AUSL Reggio Emilia Recruiting
Scandiano, RE, Italy, 42019
Contact: Fabio Fabbian, MD         fabio.fabbian@ausl.re.it    
Principal Investigator: Fabio Fabbian, MD            
Sponsors and Collaborators
Lorenzo Camellini
Investigators
Principal Investigator: Lorenzo Camellini, MD Arcispedale Santa Maria Nuova-IRCCS
Study Chair: Vincenzo Mirante, MD Nuovo Ospedale Estense - AUSL Modena
Study Chair: Veronica Iori, MD Arcispedale Santa Maria Nuova-IRCCS
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 Arcispedale Santa Maria Nuova-IRCCS
Study Chair: Giorgio Iori, Reg. Nurse Arcispedale Santa Maria Nuova-IRCCS
  More Information

Publications:

Responsible Party: Lorenzo Camellini, Consultant - Gastroenterology and Digestive Endoscopy Unit., Arcispedale Santa Maria Nuova
ClinicalTrials.gov Identifier: NCT01463540     History of Changes
Other Study ID Numbers: ASMN1PEG
Study First Received: October 30, 2011
Last Updated: August 15, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Arcispedale Santa Maria Nuova-IRCCS:
Enteral nutrition
Gastrostomy, adverse effects
Gastrostomy, nursing
Endoscopy,gastrointestinal
Surgical wound infection

ClinicalTrials.gov processed this record on May 23, 2013