Clinical trial NCT01463540: Gastrostomy Tube Placed After Gastropexy Versus Gastrostomy Tube Placed Using the Traditional Push/Pull Techniques
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastrostomy, Methods
Keywords: Enteral nutrition
Gastrostomy, adverse effects
Gastrostomy, nursing
Endoscopy,gastrointestinal
Surgical wound infection
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2011-11-02
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of patients with peristomal wound infection.
timeFrame: From the date of randomization up to 30 days, or until the date of death from any cause, whichever came first.
measure: Number of patients with major complication.
timeFrame: From the date of randomization up to 30 days, or until the date of death from any cause, whichever came first.
measure: Number of failures of positioning the gastrostomy tube.
timeFrame: From the start until the end of the endoscopic procedure.
Secondary outcomes:
measure: Mean Jain's score.
timeFrame: Jain score will be measured at follow up visits during the first month after positioning of the gastrostomy tube (on 7th, 15th, 30th days).
measure: Number of gastrostomy tube substitutions for each patient.
timeFrame: 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.
measure: Number of episodes of referral to the hospital or to any sanitary facility (outpatient clinic visit included), due to gastrostomy tube.
timeFrame: 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
measure: Days of antibiotic therapy after gastrostomy tube positioning.
timeFrame: From the date of randomization up to 30 days, or until the date of death from any cause, whichever came first.
measure: Mean time required for tube positioning, as measured in minutes.
timeFrame: From the start until the end of the endoscopic procedure.
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Digestive Endoscopy Unit - Nuovo Ospedale Estense
state: MO
city: Reggio Emilia
country: Italy
facility: Gastroenterology and Digestive Endoscopy Unit - Arcispedale Santa Maria Nuova
state: RE
city: Scandiano
country: Italy
facility: Endoscopic Unit "South Area" - AUSL Reggio Emilia
state: RE
Study officials:
affiliation: Azienda USL Reggio Emilia - IRCCS
name: Lorenzo Camellini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nuovo Ospedale Estense - AUSL Modena
name: Vincenzo Mirante, MD
role: STUDY_CHAIR
affiliation: Azienda USL Reggio Emilia - IRCCS
name: Veronica Iori, MD
role: STUDY_CHAIR
affiliation: Artificial Nutrition Interdisciplinary Team - AUSL Reggio Emilia
name: Angela Mazzocchi, MD
role: STUDY_CHAIR
affiliation: Endoscopy Unit - AUSL RE
name: Fabio Fabbian, MD
role: STUDY_CHAIR
affiliation: Nuovo Ospedale Estense - AUSL Modena
name: Rita Conigliaro, MD
role: STUDY_CHAIR
affiliation: Azienda USL Reggio Emilia - IRCCS
name: Romano Sassatelli, MD
role: STUDY_CHAIR
affiliation: Azienda USL Reggio Emilia - IRCCS
name: Giorgio Iori, Reg. Nurse
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.