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

NCT ID: NCT01463540

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2014-05-31

Brief Summary

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.

Conditions

Gastrostomy, Methods

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Push/pull endoscopic gastrostomy

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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.

Gastrostomy after gastropexy

Group Type: EXPERIMENTAL

A 20 Fr balloon type tube, placed after gastropexy.

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Kimberly Clark MIC Introducer Kit Product CODE 98423.

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorenzo Camellini, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda USL Reggio Emilia - IRCCS

Vincenzo Mirante, MD

Role: STUDY_CHAIR

Nuovo Ospedale Estense - AUSL Modena

Veronica Iori, MD

Role: STUDY_CHAIR

Azienda USL Reggio Emilia - IRCCS

Angela Mazzocchi, MD

Role: STUDY_CHAIR

Artificial Nutrition Interdisciplinary Team - AUSL Reggio Emilia

Fabio Fabbian, MD

Role: STUDY_CHAIR

Endoscopy Unit - AUSL RE

Rita Conigliaro, MD

Role: STUDY_CHAIR

Nuovo Ospedale Estense - AUSL Modena

Romano Sassatelli, MD

Role: STUDY_CHAIR

Azienda USL Reggio Emilia - IRCCS

Giorgio Iori, Reg. Nurse

Role: STUDY_CHAIR

Azienda USL Reggio Emilia - IRCCS

Locations

Digestive Endoscopy Unit - Nuovo Ospedale Estense

Modena, MO, Italy

Gastroenterology and Digestive Endoscopy Unit - Arcispedale Santa Maria Nuova

Reggio Emilia, RE, Italy

Endoscopic Unit "South Area" - AUSL Reggio Emilia

Scandiano, RE, Italy

Countries

Italy

References

Maetani I, Tada T, Ukita T, Inoue H, Sakai Y, Yoshikawa M. PEG with introducer or pull method: a prospective randomized comparison. Gastrointest Endosc. 2003 Jun;57(7):837-41. doi: 10.1016/s0016-5107(03)70017-0.

Reference Type: BACKGROUND

PMID: 12776029 (View on PubMed)

Jain NK, Larson DE, Schroeder KW, Burton DD, Cannon KP, Thompson RL, DiMagno EP. Antibiotic prophylaxis for percutaneous endoscopic gastrostomy. A prospective, randomized, double-blind clinical trial. Ann Intern Med. 1987 Dec;107(6):824-8. doi: 10.7326/0003-4819-107-6-824.

Reference Type: BACKGROUND

PMID: 3318609 (View on PubMed)

Shastri YM, Hoepffner N, Tessmer A, Ackermann H, Schroeder O, Stein J. New introducer PEG gastropexy does not require prophylactic antibiotics: multicenter prospective randomized double-blind placebo-controlled study. Gastrointest Endosc. 2008 Apr;67(4):620-8. doi: 10.1016/j.gie.2007.10.044.

Reference Type: BACKGROUND

PMID: 18374024 (View on PubMed)

Horiuchi A, Nakayama Y, Tanaka N, Fujii H, Kajiyama M. Prospective randomized trial comparing the direct method using a 24 Fr bumper-button-type device with the pull method for percutaneous endoscopic gastrostomy. Endoscopy. 2008 Sep;40(9):722-6. doi: 10.1055/s-2008-1077490. Epub 2008 Sep 4.

Reference Type: BACKGROUND

PMID: 18773341 (View on PubMed)

Other Identifiers

ASMN1PEG

Identifier Type: -

Identifier Source: org_study_id