GastroparesisGPOEMvsSHAMNCT04552184
GPOEM Versus SHAM as a Treatement of Gastroparesis
A study testing GPOEM in people with Gastroparesis, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
Objectives: To evaluate the efficacy of gastric per oral endoscopic pyloromyotomy (G-POEM) in the treatment of gastroparesis. Endpoints Primary endpoint: Clinical Efficacy Will be assessed by measurements of Gastroparesis Cardinal Symptoms Index (GCSI) score, Patient Assessment of Gastrointestinal Disorders Symptom… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Gastroparesis
- What is being tested?
- GPOEM
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Oct 2017to 1 Dec 2021
- Phase
- Interventional
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18-64 years;
- Severe refractory gastroparesis based on the presence of delayed gastric emptying-related symptoms, including nausea, retching, vomiting, abdominal pain, stomach fullness, early satiety, loss of appetite, postprandial fullness, and/or bloating. Dominant symptoms being nausea and vomiting.
- Severe refractory disease defined by symptoms related to gastroparesis with associated weight loss, failure or recurrence in patients who received available optimal pharmacologic therapies and a Gastroparesis Cardinal Symptoms Index (GCSI) score > 2.3 (calculated as mean of total subscores).
- Recent (<3 months) upper endoscopy showing no evidence of ulcerative lesions or gastric outlet obstruction
- Having delayed gastric emptying as defined by a disturbed gastric emptying scintigraphy (GES) study (half emptying time > 100 min).
- Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study specific procedures such as: clinical assessment, endoscopy, radiography, as well as laboratory investigations.
- Must be able to understand and be willing to provide written informed consent.
Who cannot join
- Achalasia and any other esophageal motility disorders.
- Heart diseases: unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity.
- Hypertension: uncontrolled hypertension during last 3 month.
- Severe renal, hepatic, pulmonary disease or cancer.
- Gastrointestinal stenosis or obstruction.
- Pregnancy or breastfeeding.
Show all 12Show fewer
- Impending gastric surgery 60 days post intervention.
- Peptic ulcer disease or tumoral lesion at endoscopy.
- Normal gastric emptying scintigraphy.
- Presence of coagulation disorders (TP < 50% and/or platelets < 50 G/l), or anesthesiologist exclusion.
- The chronic use of opioids.
- Currently participating in other study.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Gastroenterology Department, Erasme University Hospital
Brussels, 1070
Hubert LOUIS, MD, +32 2 555 5721, hubert.louis@erasme.ulb.ac.be
About this study
Official title: A Prospective Single Blinded Randomized SHAM Efficacy Study of Gastric Per Oral Endoscopic Pyloromyotomy (G-POEM) as a Treatment of Gastroparesis
Objectives: To evaluate the efficacy of gastric per oral endoscopic pyloromyotomy (G-POEM) in the treatment of gastroparesis.
Endpoints Primary endpoint: Clinical Efficacy Will be assessed by measurements of Gastroparesis Cardinal Symptoms Index (GCSI) score, Patient Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) and the 36-Item Short Form Health Survey (SF-36). Outcome criteria will be measured at baseline, 1 month, 5 months, 7 months and 12 months. These criteria will be the mean total GCSI score, and SF-36 score based on the values recorded with a Likert scale. GES parameters will be the half gastric emptying time and the RPH2.
Read more
Secondary endpoint: Safety Safety will be characterized by the incidence of all Adverse Device Effects (ADEs), non-serious and serious, possibly related to or related to the procedure and/or device that are experienced by study participants.
In addition, safety assessments will be determined based on physical examination (vital signs) and laboratory tests during scheduled visits. Safety evaluations will also be performed to ensure no subsequent adverse events have occurred and to ensure any adverse events during the trial that are considered on-going are stable or have resolved. Safety will be assessed at 1 month, 5 months, 7 months and 12 months following the intervention.
Other secondary endpoints will be technical success, nutritional status assessed by the measurement of the BMI, pre-albumin and albumin levels and for diabetics the HbA1c. These criteria will be measured at baseline, 1 month, 5 months, 7 months and 12 months.
Overall design This will be a prospective, sham-randomized, monocentric, interventional, efficacy study.
Once baseline eligibility criteria have been met, a first endoscopy under general anesthesia is proposed to the patients. Patients will be randomized blindly in a 1/1 fashion design between the sham arm and the GPOEM arm. At the time of the general anesthesia, a sealed envelope will be opened. Subjects will have a second endoscopy under general anesthesia 6 months later and the sham arm will then beneficiate from a GPOEM procedure and the GPOEM arm a sham procedure. Then, all the patients will be followed for another 6 months.
GCSI score, PAGI-SYM, SF36 will be collected at screening, 1,5,7 and 12 months. GES RPH2, RPH4 and half emptying time will be collected at screening, 5 months and 12 months.
Study procedures
Description procedure in the GPOEM arm:
The intervention will be performed under general anesthesia with tracheal intubation in supine position. GPOEM is performed with the following steps: -i: submucosal injection; -ii: mucosal incision upstream the pylorus followed by submucosal tunneling; -iii: antropyloromyotomy; -iv: closure of the tunnel access.
Description procedure in the SHAM arm:
A diagnostic upper digestive tract endoscopy will be performed under general anesthesia with tracheal intubation in supine position, injection of 1 cc of saline at four quadrants of the pylorus.
Post-operative management Once the patients recovered from anesthesia after the procedure, they were administrated analgesics and anti-emetics as needed and esomeprazole 80 mg daily systematically to protect the mucosal access and tunnel from ulceration. Patients will be kept fasted for the first postoperative day (POD 1). In the absence of adverse events, patients will be allowed to resume liquid oral intake for 1 day, a soft-ground diet for 2 additional days, and finally a normal diet. They will be discharged after POD 1 in the absence of adverse events, with a prescription of esomeprazole 40 mg daily by mouth for 1 month and dietary instructions.
After 6 months, another endoscopy under general anesthesia will be performed with the SHAM and GPOEM arms are interchanged.
After the G-POEM / SHAM procedure, all patients will be rigorously evaluated in the same fashion. They will be assessed clinically before being discharged (POD 1) and then at 1 month and 5 months after the intervention with a clinical examination that included determination of the severity of the symptoms and total GCSI score, PAGI-SYM, SF-36. A GES will be performed at 5 months and 12 months.
- Conditions
- Gastroparesis
- Being tested
- GPOEM, SHAM Procedure
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPOEMOther
gastric per oral endoscopic pyloromyotomy
SHAM ProcedureOther
intrapyloric injection of saline solution
| Study group | Role | What they receive |
|---|---|---|
| GPOEM | Active comparator | Not described Receives: Other: GPOEM |
| SHAM | Sham comparator | Not described Receives: Other: SHAM Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Efficacy will be defined by a decrease of a total Gastroparesis Cardinal Symptom Index (GCSI) symptom score of at least 0.75 points from the baseline total score of GCSI
Measured: 12 months
Assessment of Gastrointestinal Disorders Symptom Severity Index
Will be assessed by the significant improvement of the Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM), clinical score from baseline
Measured: 12 months
Quality of life
Quality of Lige will be assessed by the significant improvement of the 36-Item Short Form Health Survey (SF-36), clinical score from baseline
Measured: 12 months
Secondary outcomes (2)
Gastric Emptying Scintigraphy improvement
We will assess significant improvement Gastric Emptying Scintigraphy (GES) parameters from baseline
Measured: 12 months
Safety
Safety will be characterized by the incidence of all Adverse Device Effects (ADEs), non-serious and serious, possibly related to or related to the procedure and/or device that are experienced by study participants
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start10 Oct 2017
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552184
- Sponsor's protocol ID
- P2017/334
- Acronym
- GPOEMvsSHAM
- Status last verified
- Sep 2020
- First submitted
- 5 Sep 2018
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single Blinded Randomized SHAM Efficacy Study of Gastric Per Oral Endoscopic Pyloromyotomy (G-POEM) as a Treatment of Gastroparesis
- ClinicalTrials.gov ID
- NCT04552184
- Acronym / sponsor ID
- GPOEMvsSHAM / P2017/334
- Conditions
- Gastroparesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 17 Sep 2020 (actual)
- 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.
Objectives: To evaluate the efficacy of gastric per oral endoscopic pyloromyotomy (G-POEM) in the treatment of gastroparesis.
Endpoints Primary endpoint: Clinical Efficacy Will be assessed by measurements of Gastroparesis Cardinal Symptoms Index (GCSI) score, Patient Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) and the 36-Item Short Form Health Survey (SF-36). Outcome criteria will be measured at baseline, 1 month, 5 months, 7 months and 12 months. These criteria will be the mean total GCSI score, and SF-36 score based on the values recorded with a Likert scale. GES parameters will be the half gastric emptying time and the RPH2.
Secondary endpoint: Safety Safety will be characterized by the incidence of all Adverse Device Effects (ADEs), non-serious and serious, possibly related to or related to the procedure and/or device that are experienced by study participants.
In addition, safety assessments will be determined based on physical examination (vital signs) and laboratory tests during scheduled visits. Safety evaluations will also be performed to ensure no subsequent adverse events have occurred and to ensure any adverse events during the trial that are considered on-going are stable or have resolved. Safety will be assessed at 1 month, 5 months, 7 months and 12 months following the intervention.
Other secondary endpoints will be technical success, nutritional status assessed by the measurement of the BMI, pre-albumin and albumin levels and for diabetics the HbA1c. These criteria will be measured at baseline, 1 month, 5 months, 7 months and 12 months.
Overall design This will be a prospective, sham-randomized, monocentric, interventional, efficacy study.
Once baseline eligibility criteria have been met, a first endoscopy under general anesthesia is proposed to the patients. Patients will be randomized blindly in a 1/1 fashion design between the sham arm and the GPOEM arm. At the time of the general anesthesia, a sealed envelope will be opened. Subjects will have a second endoscopy under general anesthesia 6 months later and the sham arm will then beneficiate from a GPOEM procedure and the GPOEM arm a sham procedure. Then, all the patients will be followed for another 6 months.
GCSI score, PAGI-SYM, SF36 will be collected at screening, 1,5,7 and 12 months. GES RPH2, RPH4 and half emptying time will be collected at screening, 5 months and 12 months.
Study procedures
Description procedure in the GPOEM arm:
The intervention will be performed under general anesthesia with tracheal intubation in supine position. GPOEM is performed with the following steps: -i: submucosal injection; -ii: mucosal incision upstream the pylorus followed by submucosal tunneling; -iii: antropyloromyotomy; -iv: closure of the tunnel access.
Description procedure in the SHAM arm:
A diagnostic upper digestive tract endoscopy will be performed under general anesthesia with tracheal intubation in supine position, injection of 1 cc of saline at four quadrants of the pylorus.
Post-operative management Once the patients recovered from anesthesia after the procedure, they were administrated analgesics and anti-emetics as needed and esomeprazole 80 mg daily systematically to protect the mucosal access and tunnel from ulceration. Patients will be kept fasted for the first postoperative day (POD 1). In the absence of adverse events, patients will be allowed to resume liquid oral intake for 1 day, a soft-ground diet for 2 additional days, and finally a normal diet. They will be discharged after POD 1 in the absence of adverse events, with a prescription of esomeprazole 40 mg daily by mouth for 1 month and dietary instructions.
After 6 months, another endoscopy under general anesthesia will be performed with the SHAM and GPOEM arms are interchanged.
After the G-POEM / SHAM procedure, all patients will be rigorously evaluated in the same fashion. They will be assessed clinically before being discharged (POD 1) and then at 1 month and 5 months after the intervention with a clinical examination that included determination of the severity of the symptoms and total GCSI score, PAGI-SYM, SF-36. A GES will be performed at 5 months and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GPOEM | Active comparator | Other: GPOEM |
| SHAM | Sham comparator | Other: SHAM Procedure |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age between 18-64 years;
- Severe refractory gastroparesis based on the presence of delayed gastric emptying-related symptoms, including nausea, retching, vomiting, abdominal pain, stomach fullness, early satiety, loss of appetite, postprandial fullness, and/or bloating. Dominant symptoms being nausea and vomiting.
- Severe refractory disease defined by symptoms related to gastroparesis with associated weight loss, failure or recurrence in patients who received available optimal pharmacologic therapies and a Gastroparesis Cardinal Symptoms Index (GCSI) score > 2.3 (calculated as mean of total subscores).
- Recent (<3 months) upper endoscopy showing no evidence of ulcerative lesions or gastric outlet obstruction
- Having delayed gastric emptying as defined by a disturbed gastric emptying scintigraphy (GES) study (half emptying time > 100 min).
Key exclusion criteria (12 listed)
- Achalasia and any other esophageal motility disorders.
- Heart diseases: unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity.
- Hypertension: uncontrolled hypertension during last 3 month.
- Severe renal, hepatic, pulmonary disease or cancer.
- Gastrointestinal stenosis or obstruction.
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 |
|---|---|---|
| GPOEMgastric per oral endoscopic pyloromyotomy | Other | GPOEM |
| SHAM Procedureintrapyloric injection of saline solution | Other | SHAM |
Primary outcome
Efficacy
Time frame: 12 months
Efficacy will be defined by a decrease of a total Gastroparesis Cardinal Symptom Index (GCSI) symptom score of at least 0.75 points from the baseline total score of GCSI
Assessment of Gastrointestinal Disorders Symptom Severity Index
Time frame: 12 months
Will be assessed by the significant improvement of the Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM), clinical score from baseline
Quality of life
Time frame: 12 months
Quality of Lige will be assessed by the significant improvement of the 36-Item Short Form Health Survey (SF-36), clinical score from baseline
2 secondary outcomes
Gastric Emptying Scintigraphy improvement
Time frame: 12 months
Safety
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
Gastroenterology Department, Erasme University Hospital
Brussels, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GPOEM in people with Gastroparesis, run by Erasme University Hospital at 1 site in Belgium.
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 7 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: status not confirmed, as of the sponsor's last update on 17 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: 12 months). 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?
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 17 Sep 2020.