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

Azienda USL Reggio Emilia - IRCCS

Status and phase: Completed; Phase 4

Conditions: Gastrostomy, Methods

Treatments: Device: A 20 Fr balloon type tube, placed after gastropexy.; Device: A 20 Fr gastrostomy tube, placed using push/pull techniques.

Study type: Interventional

Funder types: Other

Identifiers

NCT01463540

ASMN1PEG

Details and patient eligibility

About

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.

Enrollment: 206 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

206 participants in 2 patient groups

Push/pull endoscopic gastrostomy

Active Comparator group

Treatment:

Device: A 20 Fr gastrostomy tube, placed using push/pull techniques.

Gastrostomy after gastropexy

Experimental group

Treatment:

Device: A 20 Fr balloon type tube, placed after gastropexy.