Gastrostomy, MethodsPhase 4NCT01463540
Gastrostomy Tube Placed After Gastropexy Versus Gastrostomy Tube Placed Using the Traditional Push/Pull Techniques
A Phase 4 study testing A 20 Fr gastrostomy tube, placed using push/pull techniques. and A 20 Fr balloon type tube, placed after gastropexy. in people with Gastrostomy, Methods, run by Azienda USL Reggio Emilia - IRCCS at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gastrostomy, Methods
- What is being tested?
- A 20 Fr gastrostomy tube, placed using push/pull techniques. and A 20 Fr balloon type tube, placed after gastropexy.
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 3 sitesItaly
- Study dates
- Sep 2010to May 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all consecutive patients, candidates to percutaneous endoscopic gastrostomy placement for any common clinical indication, in the centres participating to the study.
Who cannot join
- age < 18
- age > 85 years old
- pregnancy
- coagulation deficit or anti-coagulant oral therapy
- total gastrectomy
- absence of trans-illumination, verified during esophagogastroduodenoscopy
Show all 12Show fewer
- 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 locations and contacts
3 sites in 1 country.
Italy3 sites
Digestive Endoscopy Unit - Nuovo Ospedale Estense
Modena, MO, 41125
Gastroenterology and Digestive Endoscopy Unit - Arcispedale Santa Maria Nuova
Reggio Emilia, RE, 42125
Endoscopic Unit "South Area" - AUSL Reggio Emilia
Scandiano, RE, 42019
About this study
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
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:
Read more
- the tube can placed also in the case of an oesophageal stenosis
- studies suggest that the peristomal wound infection are less frequent using direct techniques
- 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:
- these technique are easy, but a little more cumbersome than classic push or pull maneuvers
- operators are often not familiar with direct insertion
- 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
- Being tested
- A 20 Fr gastrostomy tube, placed using push/pull techniques., A 20 Fr balloon type tube, placed after gastropexy.
- Keywords
- Enteral nutrition, Gastrostomy, adverse effects, Gastrostomy, nursing, Endoscopy,gastrointestinal, Surgical wound infection
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A 20 Fr gastrostomy tube, placed using push/pull techniques.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.
A 20 Fr balloon type tube, placed after gastropexy.Device
Also called Kimberly Clark MIC Introducer Kit Product CODE 98423.
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.
| Study group | Role | What they receive |
|---|---|---|
| Push/pull endoscopic gastrostomy | Active comparator | Not described Receives: Device: A 20 Fr gastrostomy tube, placed using push/pull techniques. |
| Gastrostomy after gastropexy | Experimental | Not described Receives: Device: A 20 Fr balloon type tube, placed after gastropexy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with peristomal wound infection.
Peristomal wound infection is defined as Jain score > 8, or presence of purulent exudates.
Measured: From the date of randomization up to 30 days, or until the date of death from any cause, whichever came first.
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.
Measured: From the date of randomization up to 30 days, or until the date of death from any cause, whichever came first.
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.
Measured: From the start until the end of the endoscopic procedure.
Secondary outcomes (5)
Mean Jain's score.
Jain's score is a validated scoring system, proposed to evaluate peristomal infection.
Measured: Jain score will be measured at follow up visits during the first month after positioning of the gastrostomy tube (on 7th, 15th, 30th days).
Number of gastrostomy tube substitutions for each patient.
The setting of the substitution will be recorded (at bed site, endoscopic unit, other sanitary facilities).
Measured: 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.
Number of episodes of referral to the hospital or to any sanitary facility (outpatient clinic visit included), due to gastrostomy tube.
Measured: 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
Days of antibiotic therapy after gastrostomy tube positioning.
Measured: From the date of randomization up to 30 days, or until the date of death from any cause, whichever came first.
Mean time required for tube positioning, as measured in minutes.
Measured: From the start until the end of the endoscopic procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2011 (estimated)
- Study startSep 2010
- Primary completionOct 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastrostomy, MethodsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Lorenzo Camellini, MD, Principal investigator, Azienda USL Reggio Emilia - IRCCSVincenzo Mirante, MD, Study chair, Nuovo Ospedale Estense - AUSL ModenaVeronica Iori, MD, Study chair, Azienda USL Reggio Emilia - IRCCSAngela Mazzocchi, MD, Study chair, Artificial Nutrition Interdisciplinary Team - AUSL Reggio EmiliaFabio Fabbian, MD, Study chair, Endoscopy Unit - AUSL RERita Conigliaro, MD, Study chair, Nuovo Ospedale Estense - AUSL ModenaRomano Sassatelli, MD, Study chair, Azienda USL Reggio Emilia - IRCCSGiorgio Iori, Reg. Nurse, Study chair, Azienda USL Reggio Emilia - IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463540
- Sponsor's protocol ID
- ASMN1PEG
- Status last verified
- Aug 2015
- First submitted
- 30 Oct 2011
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12776029Jain 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.
PubMed 3318609Shastri 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.
PubMed 18374024Horiuchi 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.
PubMed 18773341
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01463540
- Acronym / sponsor ID
- ASMN1PEG
- Conditions
- Gastrostomy, Methods
- Keywords
- Enteral nutrition, Gastrostomy, adverse effects, Gastrostomy, nursing, Endoscopy,gastrointestinal, Surgical wound infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- Sep 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 2 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- the tube can placed also in the case of an oesophageal stenosis
- studies suggest that the peristomal wound infection are less frequent using direct techniques
- 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:
- these technique are easy, but a little more cumbersome than classic push or pull maneuvers
- operators are often not familiar with direct insertion
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Push/pull endoscopic gastrostomy | Active comparator | Device: A 20 Fr gastrostomy tube, placed using push/pull techniques. |
| Gastrostomy after gastropexy | Experimental | Device: A 20 Fr balloon type tube, placed after gastropexy. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all consecutive patients, candidates to percutaneous endoscopic gastrostomy placement for any common clinical indication, in the centres participating to the study.
Key exclusion criteria (12 listed)
- age < 18
- age > 85 years old
- pregnancy
- coagulation deficit or anti-coagulant oral therapy
- total gastrectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Push/pull endoscopic gastrostomy |
| A 20 Fr balloon type tube, placed after gastropexy.Also: Kimberly Clark MIC Introducer Kit Product CODE 98423.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. | Device | Gastrostomy after gastropexy |
Primary outcome
Number of patients with peristomal wound infection.
Time frame: From the date of randomization up to 30 days, or until the date of death from any cause, whichever came first.
Peristomal wound infection is defined as Jain score > 8, or presence of purulent exudates.
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.
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.
Number of failures of positioning the gastrostomy tube.
Time frame: From the start until the end of the endoscopic procedure.
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.
5 secondary outcomes
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).
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.
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
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.
Mean time required for tube positioning, as measured in minutes.
Time frame: From the start until the end of the endoscopic procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Background: PubMed 12776029Maetani 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.
- Background: PubMed 3318609Jain 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.
- Background: PubMed 18374024Shastri 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.
- Background: PubMed 18773341Horiuchi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenzo Camellini, MD principal investigator
Azienda USL Reggio Emilia - IRCCS
Vincenzo Mirante, MD study chair
Nuovo Ospedale Estense - AUSL Modena
Veronica Iori, MD study chair
Azienda USL Reggio Emilia - IRCCS
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing A 20 Fr gastrostomy tube, placed using push/pull techniques. and A 20 Fr balloon type tube, placed after gastropexy. in people with Gastrostomy, Methods, run by Azienda USL Reggio Emilia - IRCCS at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with peristomal wound infection. (time frame: From the date of randomization up to 30 days, or until the date of death from any cause, whichever came first.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01463540, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.