Gastrostomy, Methods Clinical Trial
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
| Verified date | August 2015 |
| Source | Arcispedale Santa Maria Nuova-IRCCS |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 206 |
| Est. completion date | May 2014 |
| Est. primary completion date | October 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 85 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Lorenzo Camellini |
Italy,
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. — View 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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of patients with peristomal wound infection. | 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. | Yes |
| Primary | Number of patients with major complication. | 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. | Yes |
| Primary | Number of failures of positioning the gastrostomy tube. | 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. | Yes |
| Secondary | Mean Jain's score. | 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). | Yes |
| Secondary | Number of gastrostomy tube substitutions for each patient. | 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. | No |
| Secondary | Number of episodes of referral to the hospital or to any sanitary facility (outpatient clinic visit included), due to gastrostomy tube. | 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 | No | |
| Secondary | Days of antibiotic therapy after gastrostomy tube positioning. | From the date of randomization up to 30 days, or until the date of death from any cause, whichever came first. | Yes | |
| Secondary | Mean time required for tube positioning, as measured in minutes. | From the start until the end of the endoscopic procedure. | No |