AchalasiaNCT05041608
Endoscopic Surgery for Gastrointestinal Disorders: A Multicenter Registry Study
An observational study of Achalasia and Gastric Outlet Obstruction, run by Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University at 1 site in United States.
Trial summary
Currently, there is limited multi-center data on endoscopic surgery outcomes in western populations. Evaluation of these measurement would help the investigators compare them to conventional treatment modalities within current tertiary facilities; and consequently help the investigators identify appropriate treatment… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Achalasia, Gastric Outlet Obstruction, Gastroparesis
- What is being tested?
- Endoscopic Surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2021to 16 Dec 2024
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects undergoing Endoscopic Surgery for various Gastrointestinal indications
Who may be able to join
- Subjects undergoing Endoscopic Surgery
Who cannot join
- Subjects not undergoing Endoscopic Surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
New Brunswick, New Jersey, 08901
About this study
Currently, there is limited multi-center data on endoscopic surgery outcomes in western populations.
Evaluation of these measurement would help the investigators compare them to conventional treatment modalities within current tertiary facilities; and consequently help the investigators identify appropriate treatment techniques and improve clinical management of patients at Rutgers RWJMS.
The purpose of this retrospective registry study is to assess long term data on efficacy, safety and clinical outcome of Endoscopic Surgery within the gastrointestinal tract.
Read the detailed description
Our tertiary-care institution performs clinically-indicated various Endoscopic Surgery procedures gastrointestinal indications in more than 800-1000 patients annually.
The study investigators would collect data on a large sample size of subjects undergoing various endoscopic resection procedures such as POEM (Peroral Endoscopic Myotomy), EMR (Endoscopic Mucosal Resection), ESD (Endoscopic submucosal dissection), STER (Submucosal tunneling endoscopic resection), NOTES (Natural Orifice Translumenal Endoscopic Surgery), TIF (Transoral Incisionless Fundoplication), Endoscopic Fistula Closure, Endoscopic Suturing, Capsule Endoscopy and EFTR (Endoscopic full-thickness resection). Clinical metrics will be collected including procedure times, length of follow-up, specific tumor characteristics, resection method, pathology results, procedural complications, additional therapy required, and disease-free survival time.
Various endoscopic surgical procedures are less invasive than traditional surgery, have fewer side effects and provide better efficacy. Moreover, they can be available to patients who are ineligible for surgery or who have refused more aggressive surgical intervention.
They improve quality of life and extend survival duration.
Endoscopic surgery procedures can be an appropriate approach in many gastrointestinal disorders including early neoplasms, challenging adenomas or sub-epithelial lesions that requires the resection of the superficial layers, mucosa and submucosa, or full thickness resection of the tract wall.
Currently, there is limited multi-center data on endoscopic surgery outcomes in western populations.
Evaluation of these measurement would help the investigators compare them to conventional treatment modalities within current tertiary facilities; and consequently help the investigators identify appropriate treatment techniques and improve clinical management of patients at Rutgers RWJMS.
The purpose of this retrospective registry study is to assess long term data on efficacy, safety and clinical outcome of Endoscopic Surgery within the gastrointestinal tract.
- Conditions
- Achalasia, Gastric Outlet Obstruction, Gastroparesis, GERD, Reflux, Fistula
- Being tested
- Endoscopic Surgery
- Keywords
- POEM, ESD, STER, EFTR, EMR, NOTES, TIF, Capsule Endoscopy, Endoscopic suturing, Endoscopic Fistula Closure, ZPOEM, GPOEM
- Medical subject headings
- Esophageal Achalasia, Gastric Outlet Obstruction, Gastroparesis, Gastroesophageal Reflux, Fistula, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic SurgeryProcedure or surgery
These procedures include: POEM (Peroral Endoscopic Myotomy) for Achalasia, G-POEM (Gastric Peroral Endoscopic Myotomy) for gastric outlet obstruction, Z-POEM (Peroral endoscopic myotomy for Zenker's Diverticulum), EMR (Endoscopic Mucosal Resection), ESD (Endoscopic submucosal dissection), STER (Submucosal tunneling endoscopic resection), NOTES (Natural Orifice Translumenal Endoscopic Surgery), TIF (Transoral Incisionless Fundoplication), Endoscopic Fistula Closure, Endoscopic Suturing, Capsule Endoscopy and EFTR (Endoscopic full-thickness resection).
| Study group | Role | What they receive |
|---|---|---|
| Subjects undergoing Endoscopic Surgery | These procedures include: POEM (Peroral Endoscopic Myotomy) for Achalasia, G-POEM (Gastric Peroral Endoscopic Myotomy) for gastric outlet obstruction, Z-POEM (Peroral endoscopic myotomy for Zenker's Diverticulum), EMR (Endoscopic Mucosal Resection), ESD (Endoscopic submucosal dissection), STER (Submucosal tunneling endoscopic resection), NOTES (Natural Orifice Translumenal Endoscopic Surgery), TIF (Transoral Incisionless Fundoplication), Endoscopic Fistula Closure, Endoscopic Suturing, Capsule Endoscopy and EFTR (Endoscopic full-thickness resection). Receives: Procedure: Endoscopic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of procedure
Technical and clinical success rate
Measured: Upto 1 year
Safety of procedure
Type, frequency and intensity of adverse events
Measured: Upto 1 year
Secondary outcomes (1)
Quality of Life after procedure
Chart Review of quality-of-life improvement and overall survival duration
Measured: Upto 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start17 Feb 2021
- Primary completion16 Dec 2023 (estimated)
- Study completion16 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AchalasiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Kahaleh, MD, Principal investigator, Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041608
- Sponsor's protocol ID
- Pro2020002798
- Status last verified
- May 2023
- First submitted
- 3 Sep 2021
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared with other researchers.
Publications
Shahid HM, Bareket R, Tyberg A, Sarkar A, Simon A, Gurram K, Gress FG, Bhenswala P, Chalikonda D, Loren DE, Kowalski TE, Kumar A, Vareedayah AA, Abhyankar PR, Parker K, Gabr MM, Nieto J, De Latour R, Zolotarevsky M 5th, Barber J, Zolotarevsky E, Vazquez-Sequeiros E, Gaidhane M, Andalib I, Kahaleh M. Comparing the Safety and Efficacy of Two Commercially Available Single-Use Duodenoscopes: A Multicenter Study. J Clin Gastroenterol. 2023 Sep 1;57(8):798-803. doi: 10.1097/MCG.0000000000001752.
PubMed 35997700Shah-Khan SM, Zhao E, Tyberg A, Sarkar S, Shahid HM, Duarte-Chavez R, Gaidhane M, Kahaleh M. Endoscopic Ultrasound-Directed Transgastric ERCP (EDGE) Utilization of Trends Among Interventional Endoscopists. Dig Dis Sci. 2023 Apr;68(4):1167-1177. doi: 10.1007/s10620-022-07650-1. Epub 2022 Aug 10.
PubMed 35947304
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Surgery for Gastrointestinal Disorders: A Multicenter Registry Study
- ClinicalTrials.gov ID
- NCT05041608
- Acronym / sponsor ID
- Pro2020002798
- Conditions
- Achalasia, Gastric Outlet Obstruction, Gastroparesis, GERD, Reflux, Fistula
- Keywords
- POEM, ESD, STER, EFTR, EMR, NOTES, TIF, Capsule Endoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers UniversityUniversity, hospital or other
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- 16 Dec 2023 (estimated)
- Study completion
- 16 Dec 2024 (estimated)
- First posted
- 13 Sep 2021 (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, there is limited multi-center data on endoscopic surgery outcomes in western populations.
Evaluation of these measurement would help the investigators compare them to conventional treatment modalities within current tertiary facilities; and consequently help the investigators identify appropriate treatment techniques and improve clinical management of patients at Rutgers RWJMS.
The purpose of this retrospective registry study is to assess long term data on efficacy, safety and clinical outcome of Endoscopic Surgery within the gastrointestinal tract.
Detailed description
Our tertiary-care institution performs clinically-indicated various Endoscopic Surgery procedures gastrointestinal indications in more than 800-1000 patients annually.
The study investigators would collect data on a large sample size of subjects undergoing various endoscopic resection procedures such as POEM (Peroral Endoscopic Myotomy), EMR (Endoscopic Mucosal Resection), ESD (Endoscopic submucosal dissection), STER (Submucosal tunneling endoscopic resection), NOTES (Natural Orifice Translumenal Endoscopic Surgery), TIF (Transoral Incisionless Fundoplication), Endoscopic Fistula Closure, Endoscopic Suturing, Capsule Endoscopy and EFTR (Endoscopic full-thickness resection). Clinical metrics will be collected including procedure times, length of follow-up, specific tumor characteristics, resection method, pathology results, procedural complications, additional therapy required, and disease-free survival time.
Various endoscopic surgical procedures are less invasive than traditional surgery, have fewer side effects and provide better efficacy. Moreover, they can be available to patients who are ineligible for surgery or who have refused more aggressive surgical intervention.
They improve quality of life and extend survival duration.
Endoscopic surgery procedures can be an appropriate approach in many gastrointestinal disorders including early neoplasms, challenging adenomas or sub-epithelial lesions that requires the resection of the superficial layers, mucosa and submucosa, or full thickness resection of the tract wall.
Currently, there is limited multi-center data on endoscopic surgery outcomes in western populations.
Evaluation of these measurement would help the investigators compare them to conventional treatment modalities within current tertiary facilities; and consequently help the investigators identify appropriate treatment techniques and improve clinical management of patients at Rutgers RWJMS.
The purpose of this retrospective registry study is to assess long term data on efficacy, safety and clinical outcome of Endoscopic Surgery within the gastrointestinal tract.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects undergoing Endoscopic Surgery | – | Procedure: Endoscopic SurgeryThese procedures include: POEM (Peroral Endoscopic Myotomy) for Achalasia, G-POEM (Gastric Peroral Endoscopic Myotomy) for gastric outlet obstruction, Z-POEM (Peroral endoscopic myotomy for Zenker's Diverticulum), EMR (Endoscopic Mucosal Resection), ESD (Endoscopic submucosal dissection), STER (Submucosal tunneling endoscopic resection), NOTES (Natural Orifice Translumenal Endoscopic Surgery), TIF (Transoral Incisionless Fundoplication), Endoscopic Fistula Closure, Endoscopic Suturing, Capsule Endoscopy and EFTR (Endoscopic full-thickness resection). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects undergoing Endoscopic Surgery for various Gastrointestinal indications
Key inclusion criteria (1 listed)
- Subjects undergoing Endoscopic Surgery
Key exclusion criteria (1 listed)
- Subjects not undergoing Endoscopic Surgery
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 SurgeryThese procedures include: POEM (Peroral Endoscopic Myotomy) for Achalasia, G-POEM (Gastric Peroral Endoscopic Myotomy) for gastric outlet obstruction, Z-POEM (Peroral endoscopic myotomy for Zenker's Diverticulum), EMR (Endoscopic Mucosal Resection), ESD (Endoscopic submucosal dissection), STER (Submucosal tunneling endoscopic resection), NOTES (Natural Orifice Translumenal Endoscopic Surgery), TIF (Transoral Incisionless Fundoplication), Endoscopic Fistula Closure, Endoscopic Suturing, Capsule Endoscopy and EFTR (Endoscopic full-thickness resection). | Procedure or surgery | Subjects undergoing Endoscopic Surgery |
Primary outcome
Efficacy of procedure
Time frame: Upto 1 year
Technical and clinical success rate
Safety of procedure
Time frame: Upto 1 year
Type, frequency and intensity of adverse events
1 secondary outcome
Quality of Life after procedure
Time frame: Upto 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Derived from this study: PubMed 35997700Shahid HM, Bareket R, Tyberg A, Sarkar A, Simon A, Gurram K, Gress FG, Bhenswala P, Chalikonda D, Loren DE, Kowalski TE, Kumar A, Vareedayah AA, Abhyankar PR, Parker K, Gabr MM, Nieto J, De Latour R, Zolotarevsky M 5th, Barber J, Zolotarevsky E, Vazquez-Sequeiros E, Gaidhane M, Andalib I, Kahaleh M. Comparing the Safety and Efficacy of Two Commercially Available Single-Use Duodenoscopes: A Multicenter Study. J Clin Gastroenterol. 2023 Sep 1;57(8):798-803. doi: 10.1097/MCG.0000000000001752.
- Derived from this study: PubMed 35947304Shah-Khan SM, Zhao E, Tyberg A, Sarkar S, Shahid HM, Duarte-Chavez R, Gaidhane M, Kahaleh M. Endoscopic Ultrasound-Directed Transgastric ERCP (EDGE) Utilization of Trends Among Interventional Endoscopists. Dig Dis Sci. 2023 Apr;68(4):1167-1177. doi: 10.1007/s10620-022-07650-1. Epub 2022 Aug 10.
- Individual participant dataSharing planned: No. Data will not be shared with other researchers.
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Achalasia
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.
Michel Kahaleh, MD principal investigator
Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Achalasia and Gastric Outlet Obstruction, run by Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University at 1 site in United States.
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 1 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 26 May 2023. 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 United States. 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?
Efficacy of procedure (time frame: Upto 1 year). The study lists 2 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 NCT05041608, which also lists 2 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 26 May 2023.