GERDRESECT-RGONCT03357809
Endoscopic Resection in Gastro-Esophageal Reflux Disease
A study testing Endoscopic mucosal resection in people with GERD and Gastro Esophageal Reflux, run by Hospital St. Joseph, Marseille, France at 1 site in France.
Trial summary
Currently patients with gastroesophageal reflux disease (GERD) are treated with proton pump inhibitors (PPIs). This long-term PPI treatment would likely increase the risk of pulmonary and digestive infections and would not prevent evolution to adenocarcinoma of Barrett's Esophagus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GERD, Gastro Esophageal Reflux
- What is being tested?
- Endoscopic mucosal resection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 10 Apr 2017to 10 Apr 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with GERD resistant to medical treatment, or requiring daily long-term medical treatment
Who cannot join
- Contraindications to the realization of a upper GI endoscopy
- Achalasia or other esophageal motor disorders
- Voluminous hiatal hernia Haemorrhagic, haemostasis or coagulation disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monocentric Study Evaluating the Efficiency and Safety of Anti-reflux Mucosectomy ARMS for the Gastro-Esophageal Reflux Disease
Currently patients with gastroesophageal reflux disease (GERD) are treated with proton pump inhibitors (PPIs). This long-term PPI treatment would likely increase the risk of pulmonary and digestive infections and would not prevent evolution to adenocarcinoma of Barrett's Esophagus. Surgical fundoplication is generally recommended when symptoms are poorly controlled with PPIs and considered as standard treatment despite celioscopy risk. A variety of endoscopic techniques for the treatment of GERD has been proposed to obtain non-surgical control. These endoscopic techniques aim to bring the tissues closer to the Œsogastric (JOG) junction. But a low response rate has been demonstrated with these techniques.
- Inoue (inventor of the anti-reflux mucosectomy 20 years ago) and his team postulated that the reflux symptoms would be reduced by creating a relative restriction of gastric cardia. The healing of the mucosectomy zone led to restriction of gastric cardia. This observation suggested that ARMS could represent an effective anti-reflux procedure with the advantage that no prostheses would be left in situ.
Few studies have evaluated this new endoscopic technique. The purpose of this study is to evaluate the feasibility and safety of gastric mucosectomy for patients with GERD resistant to medical treatment or requiring long-term maintenance medical treatment.
Read the detailed description
This is a monocentric prospective therapeutic study. Patients will be recruited in hepato-gastroenterology department of Saint Joseph Hospital (Marseille). A first clinical, endoscopic and PH impedance evaluation will be made. Mucosectomy will be scheduled depending on the results of the review.
The patients will be followed for 2 years with esophageal and gastric PH-impedance monitoring at 6 months and 24 months. Health related quality of life questionnaires will be completed before ARMS, 6 and 24 months after mucosectomy.
The characteristics of the patients will be compared to evaluate the % of responders and non-responders
- Conditions
- GERD, Gastro Esophageal Reflux
- Being tested
- Endoscopic mucosal resection
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic mucosal resectionProcedure or surgery
Mucosectomy performed at day 1. Endoscopic mucosal resection (EMR) and or endoscopic submucosal dissection (ESD), is at least 3 cm long. The mucosal resection is carried out along the side of the small curvature of the stomach, in order to preserve a valve of the cardia at the level of the large curvature of the stomach.
A coloured solution is injected into the submucosa following markers. The correct submucosal injection is confirmed by the lifting of the mucosal surface. A submucosal dissection is carried out using the dual knife. The mucosectomy is repeatedly performed until the mucosal zone is completely resected. The choice of the resection technique will depend on the anatomy of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic treatment | Experimental | ENDOSCOPIC MUCOSAL RESECTION AT DAY 1 Receives: Procedure: Endoscopic mucosal resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients no longer requiring medical treatment at 6 months
Suggest that endoscopic treatment would allow the cessation of medical treatment in 50% of cases Rate of patients no longer requiring medical treatment at 6 months
Measured: 6 months
Secondary outcomes (3)
Improvement in quality of life
Percentage of improvement in quality of life measured by the score obtained in the GERD-HRQL questionnaire evaluating the impact of GERD on quality of life.
Measured: 6 months
Improvement of gastric PH
Improvement of gastric PH metric dosages.
Measured: 6 months
Evaluation for morbidity
Rate of all observed complications in per and post immediate procedure (up to 30 minutes). The delayed morbidity of the procedure for the study will be defined by the rate of complications occurring after the examination and up to 30 days. Specially, the following events will be studied: digestive hemorrhage and digestive perforation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start10 Apr 2017
- Primary completion10 Apr 2019 (estimated)
- Study completion10 Apr 2023 (estimated)
Why it stopped: lake of efficiency and poor tolerance of endoscopic technique
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for GERDStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital St. Joseph, Marseille, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arthur Laquiere, Hospital St. Joseph, Marseille, France
- Investigators
- Arthur Laquière, MD, Principal investigator, French Society of Digestive Endoscopy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357809
- Sponsor's protocol ID
- 2016-A01591-50
- Acronym
- RESECT-RGO
- Status last verified
- Apr 2019
- First submitted
- 13 Oct 2017
- Last updated
- 4 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Galmiche JP, Hatlebakk J, Attwood S, Ell C, Fiocca R, Eklund S, Langstrom G, Lind T, Lundell L; LOTUS Trial Collaborators. Laparoscopic antireflux surgery vs esomeprazole treatment for chronic GERD: the LOTUS randomized clinical trial. JAMA. 2011 May 18;305(19):1969-77. doi: 10.1001/jama.2011.626.
PubMed 21586712Cicala M, Emerenziani S, Guarino MP, Ribolsi M. Proton pump inhibitor resistance, the real challenge in gastro-esophageal reflux disease. World J Gastroenterol. 2013 Oct 21;19(39):6529-35. doi: 10.3748/wjg.v19.i39.6529.
PubMed 24151377Kellokumpu I, Voutilainen M, Haglund C, Farkkila M, Roberts PJ, Kautiainen H. Quality of life following laparoscopic Nissen fundoplication: assessing short-term and long-term outcomes. World J Gastroenterol. 2013 Jun 28;19(24):3810-8. doi: 10.3748/wjg.v19.i24.3810.
PubMed 23840119Marret H, Pierre F, Chapron C, Perrotin F, Body G, Lansac J. [Complications of laparoscopy caused by trocars. Preliminary study from the national registry of the French Society of Gynecologic Endoscopy]. J Gynecol Obstet Biol Reprod (Paris). 1997;26(4):405-12. French.
PubMed 9265066Rickenbacher N, Kotter T, Kochen MM, Scherer M, Blozik E. Fundoplication versus medical management of gastroesophageal reflux disease: systematic review and meta-analysis. Surg Endosc. 2014 Jan;28(1):143-55. doi: 10.1007/s00464-013-3140-z. Epub 2013 Sep 10.
PubMed 24018760Mahmood Z, Byrne PJ, McMahon BP, Murphy EM, Arfin Q, Ravi N, Weir DG, Reynolds JV. Comparison of transesophageal endoscopic plication (TEP) with laparoscopic Nissen fundoplication (LNF) in the treatment of uncomplicated reflux disease. Am J Gastroenterol. 2006 Mar;101(3):431-6. doi: 10.1111/j.1572-0241.2006.00534.x.
PubMed 16542276Triadafilopoulos G. Stretta: a valuable endoscopic treatment modality for gastroesophageal reflux disease. World J Gastroenterol. 2014 Jun 28;20(24):7730-8. doi: 10.3748/wjg.v20.i24.7730.
PubMed 24976710Feretis C, Benakis P, Dimopoulos C, Dailianas A, Filalithis P, Stamou KM, Manouras A, Apostolidis N. Endoscopic implantation of Plexiglas (PMMA) microspheres for the treatment of GERD. Gastrointest Endosc. 2001 Apr;53(4):423-6. doi: 10.1067/mge.2001.113912.
PubMed 11275880Cicala M, Gabbrielli A, Emerenziani S, Guarino MP, Ribolsi M, Caviglia R, Costamagna G. Effect of endoscopic augmentation of the lower oesophageal sphincter (Gatekeeper reflux repair system) on intraoesophageal dynamic characteristics of acid reflux. Gut. 2005 Feb;54(2):183-6. doi: 10.1136/gut.2004.040501.
PubMed 15647177Wong RF, Davis TV, Peterson KA. Complications involving the mediastinum after injection of Enteryx for GERD. Gastrointest Endosc. 2005 May;61(6):753-6. doi: 10.1016/s0016-5107(04)02645-8. No abstract available.
PubMed 15855987Chuttani R, Sud R, Sachdev G, Puri R, Kozarek R, Haber G, Pleskow D, Zaman M, Lembo A. A novel endoscopic full-thickness plicator for the treatment of GERD: A pilot study. Gastrointest Endosc. 2003 Nov;58(5):770-6. doi: 10.1016/s0016-5107(03)02027-3.
PubMed 14595322Cadiere GB, Buset M, Muls V, Rajan A, Rosch T, Eckardt AJ, Weerts J, Bastens B, Costamagna G, Marchese M, Louis H, Mana F, Sermon F, Gawlicka AK, Daniel MA, Deviere J. Antireflux transoral incisionless fundoplication using EsophyX: 12-month results of a prospective multicenter study. World J Surg. 2008 Aug;32(8):1676-88. doi: 10.1007/s00268-008-9594-9.
PubMed 18443855Satodate H, Inoue H, Yoshida T, Usui S, Iwashita M, Fukami N, Shiokawa A, Kudo SE. Circumferential EMR of carcinoma arising in Barrett's esophagus: case report. Gastrointest Endosc. 2003 Aug;58(2):288-92. doi: 10.1067/mge.2003.361. No abstract available.
PubMed 12872107Inoue H, Ito H, Ikeda H, Sato C, Sato H, Phalanusitthepha C, Hayee B, Eleftheriadis N, Kudo SE. Anti-reflux mucosectomy for gastroesophageal reflux disease in the absence of hiatus hernia: a pilot study. Ann Gastroenterol. 2014;27(4):346-351.
PubMed 25330784Velanovich V, Vallance SR, Gusz JR, Tapia FV, Harkabus MA. Quality of life scale for gastroesophageal reflux disease. J Am Coll Surg. 1996 Sep;183(3):217-24.
PubMed 8784314
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Study Evaluating the Efficiency and Safety of Anti-reflux Mucosectomy ARMS for the Gastro-Esophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT03357809
- Acronym / sponsor ID
- RESECT-RGO / 2016-A01591-50
- Conditions
- GERD, Gastro Esophageal Reflux
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: lake of efficiency and poor tolerance of endoscopic technique
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hospital St. Joseph, Marseille, FranceUniversity, hospital or other
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 10 Apr 2019 (estimated)
- Study completion
- 10 Apr 2023 (estimated)
- First posted
- 30 Nov 2017 (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.
Currently patients with gastroesophageal reflux disease (GERD) are treated with proton pump inhibitors (PPIs). This long-term PPI treatment would likely increase the risk of pulmonary and digestive infections and would not prevent evolution to adenocarcinoma of Barrett's Esophagus. Surgical fundoplication is generally recommended when symptoms are poorly controlled with PPIs and considered as standard treatment despite celioscopy risk. A variety of endoscopic techniques for the treatment of GERD has been proposed to obtain non-surgical control. These endoscopic techniques aim to bring the tissues closer to the Œsogastric (JOG) junction. But a low response rate has been demonstrated with these techniques.
- Inoue (inventor of the anti-reflux mucosectomy 20 years ago) and his team postulated that the reflux symptoms would be reduced by creating a relative restriction of gastric cardia. The healing of the mucosectomy zone led to restriction of gastric cardia. This observation suggested that ARMS could represent an effective anti-reflux procedure with the advantage that no prostheses would be left in situ.
Few studies have evaluated this new endoscopic technique. The purpose of this study is to evaluate the feasibility and safety of gastric mucosectomy for patients with GERD resistant to medical treatment or requiring long-term maintenance medical treatment.
Detailed description
This is a monocentric prospective therapeutic study. Patients will be recruited in hepato-gastroenterology department of Saint Joseph Hospital (Marseille). A first clinical, endoscopic and PH impedance evaluation will be made. Mucosectomy will be scheduled depending on the results of the review.
The patients will be followed for 2 years with esophageal and gastric PH-impedance monitoring at 6 months and 24 months. Health related quality of life questionnaires will be completed before ARMS, 6 and 24 months after mucosectomy.
The characteristics of the patients will be compared to evaluate the % of responders and non-responders
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic treatment | Experimental | Procedure: Endoscopic mucosal resectionENDOSCOPIC MUCOSAL RESECTION AT DAY 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with GERD resistant to medical treatment, or requiring daily long-term medical treatment
Key exclusion criteria (3 listed)
- Contraindications to the realization of a upper GI endoscopy
- Achalasia or other esophageal motor disorders
- Voluminous hiatal hernia Haemorrhagic, haemostasis or coagulation disorders
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 |
|---|---|---|
| Endoscopic mucosal resectionMucosectomy performed at day 1. Endoscopic mucosal resection (EMR) and or endoscopic submucosal dissection (ESD), is at least 3 cm long. The mucosal resection is carried out along the side of the small curvature of the stomach, in order to preserve a valve of the cardia at the level of the large curvature of the stomach. A coloured solution is injected into the submucosa following markers. The correct submucosal injection is confirmed by the lifting of the mucosal surface. A submucosal dissection is carried out using the dual knife. The mucosectomy is repeatedly performed until the mucosal zone is completely resected. The choice of the resection technique will depend on the anatomy of the patient. | Procedure or surgery | Endoscopic treatment |
Primary outcome
Rate of patients no longer requiring medical treatment at 6 months
Time frame: 6 months
Suggest that endoscopic treatment would allow the cessation of medical treatment in 50% of cases Rate of patients no longer requiring medical treatment at 6 months
3 secondary outcomes
Improvement in quality of life
Time frame: 6 months
Improvement of gastric PH
Time frame: 6 months
Evaluation for morbidity
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Results publication: PubMed 21586712Galmiche JP, Hatlebakk J, Attwood S, Ell C, Fiocca R, Eklund S, Langstrom G, Lind T, Lundell L; LOTUS Trial Collaborators. Laparoscopic antireflux surgery vs esomeprazole treatment for chronic GERD: the LOTUS randomized clinical trial. JAMA. 2011 May 18;305(19):1969-77. doi: 10.1001/jama.2011.626.
- Results publication: PubMed 24151377Cicala M, Emerenziani S, Guarino MP, Ribolsi M. Proton pump inhibitor resistance, the real challenge in gastro-esophageal reflux disease. World J Gastroenterol. 2013 Oct 21;19(39):6529-35. doi: 10.3748/wjg.v19.i39.6529.
- Results publication: PubMed 23840119Kellokumpu I, Voutilainen M, Haglund C, Farkkila M, Roberts PJ, Kautiainen H. Quality of life following laparoscopic Nissen fundoplication: assessing short-term and long-term outcomes. World J Gastroenterol. 2013 Jun 28;19(24):3810-8. doi: 10.3748/wjg.v19.i24.3810.
- Results publication: PubMed 9265066Marret H, Pierre F, Chapron C, Perrotin F, Body G, Lansac J. [Complications of laparoscopy caused by trocars. Preliminary study from the national registry of the French Society of Gynecologic Endoscopy]. J Gynecol Obstet Biol Reprod (Paris). 1997;26(4):405-12. French.
- Results publication: PubMed 24018760Rickenbacher N, Kotter T, Kochen MM, Scherer M, Blozik E. Fundoplication versus medical management of gastroesophageal reflux disease: systematic review and meta-analysis. Surg Endosc. 2014 Jan;28(1):143-55. doi: 10.1007/s00464-013-3140-z. Epub 2013 Sep 10.
- Results publication: PubMed 16542276Mahmood Z, Byrne PJ, McMahon BP, Murphy EM, Arfin Q, Ravi N, Weir DG, Reynolds JV. Comparison of transesophageal endoscopic plication (TEP) with laparoscopic Nissen fundoplication (LNF) in the treatment of uncomplicated reflux disease. Am J Gastroenterol. 2006 Mar;101(3):431-6. doi: 10.1111/j.1572-0241.2006.00534.x.
- Results publication: PubMed 24976710Triadafilopoulos G. Stretta: a valuable endoscopic treatment modality for gastroesophageal reflux disease. World J Gastroenterol. 2014 Jun 28;20(24):7730-8. doi: 10.3748/wjg.v20.i24.7730.
- Results publication: PubMed 11275880Feretis C, Benakis P, Dimopoulos C, Dailianas A, Filalithis P, Stamou KM, Manouras A, Apostolidis N. Endoscopic implantation of Plexiglas (PMMA) microspheres for the treatment of GERD. Gastrointest Endosc. 2001 Apr;53(4):423-6. doi: 10.1067/mge.2001.113912.
- Results publication: PubMed 15647177Cicala M, Gabbrielli A, Emerenziani S, Guarino MP, Ribolsi M, Caviglia R, Costamagna G. Effect of endoscopic augmentation of the lower oesophageal sphincter (Gatekeeper reflux repair system) on intraoesophageal dynamic characteristics of acid reflux. Gut. 2005 Feb;54(2):183-6. doi: 10.1136/gut.2004.040501.
- Results publication: PubMed 15855987Wong RF, Davis TV, Peterson KA. Complications involving the mediastinum after injection of Enteryx for GERD. Gastrointest Endosc. 2005 May;61(6):753-6. doi: 10.1016/s0016-5107(04)02645-8. No abstract available.
- Results publication: PubMed 14595322Chuttani R, Sud R, Sachdev G, Puri R, Kozarek R, Haber G, Pleskow D, Zaman M, Lembo A. A novel endoscopic full-thickness plicator for the treatment of GERD: A pilot study. Gastrointest Endosc. 2003 Nov;58(5):770-6. doi: 10.1016/s0016-5107(03)02027-3.
- Results publication: PubMed 18443855Cadiere GB, Buset M, Muls V, Rajan A, Rosch T, Eckardt AJ, Weerts J, Bastens B, Costamagna G, Marchese M, Louis H, Mana F, Sermon F, Gawlicka AK, Daniel MA, Deviere J. Antireflux transoral incisionless fundoplication using EsophyX: 12-month results of a prospective multicenter study. World J Surg. 2008 Aug;32(8):1676-88. doi: 10.1007/s00268-008-9594-9.
- Individual participant dataSharing planned: No
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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.
Arthur Laquière, MD principal investigator
French Society of Digestive Endoscopy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic mucosal resection in people with GERD and Gastro Esophageal Reflux, run by Hospital St. Joseph, Marseille, France at 1 site in France.
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 3 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: paused, as of the sponsor's last update on 4 Apr 2019. 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 France. 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.
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?
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?
Rate of patients no longer requiring medical treatment at 6 months (time frame: 6 months). 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 NCT03357809, which also lists 16 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 4 Apr 2019.