AchalasiaNCT05214443
POEM + F for Achalasia - a Pilot Study
A study testing POEM + F in people with Achalasia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a pilot study to investigate the feasibility of performing per-oral endoscopic Myotomy (POEM) with endoscopic fundoplication for patient with achalasia. Post-POEM reflux is a well documented adverse event after POEM for achalasia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achalasia
- What is being tested?
- POEM + F
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteHong Kong
- Study dates
- 24 Mar 2022to 30 Jun 2024
- 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
- Patients with achalasia diagnosed with high resolution manometry, scheduled for elective per-oral endoscopic myotomy
- Age >18
Who cannot join
- Prior treatment for achalasia, including surgical myotomy, dilatation or POEM.
- Prior upper abdominal surgery
- Other cases deemed by the examining physician as unsuitable for safe treatment
- Patients who refused to participate
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong
Hon Chi Yip, FRCSEd, +85235052627, hcyip@surgery.cuhk.edu.hk
About this study
Official title: Per-oral Endoscopic Myotomy With Fundoplication (POEM+F) for Achalasia - a Pilot Study
This is a pilot study to investigate the feasibility of performing per-oral endoscopic Myotomy (POEM) with endoscopic fundoplication for patient with achalasia. Post-POEM reflux is a well documented adverse event after POEM for achalasia. Case series have been published by addition of endoscopic fundoplication procedure during POEM. In the current study, 10 patients would be recruited for investigating the novel POEM procedure with fundoplication by using a new X-tack anchoring device.
Read the detailed description
Since the first published case series, per-oral endoscopic myotomy (POEM) has emerged as one of the standard treatment options for achalasia. The procedure offers a scarless endoscopic alternative to conventional surgical myotomy. In a recent randomized controlled trial, POEM was found to achieve similar treatment success rate when compared with surgical myotomy. POEM was also found to have reduced serious adverse events. When compared with endoscopic pneumatic dilatation, POEM was demonstrated to have a significantly higher clinical success rate.
One of the major limitations of POEM was the higher incidence of post-procedural acid reflux. During surgical myotomy, a partial fundoplication would routinely be performed to reinforce the gastro-esophageal junction, and such procedure has been proven to reduce post-operative reflux. Multiple studies have confirmed the higher incidence of endoscopic reflux esophagitis and proton pump requirements after POEM than surgical myotomy, including the aforementioned randomized trial.
Modification and standardization of the POEM techniques were proposed to reduce the incidence of reflux esophagitis. Limitation of gastric myotomy length to below 2cm was found to be a useful maneuver. Identification of the two penetrating vessels at cardia may help to correctly measure the length of gastric myotomy, together with the use of double scope technique.
In an attempt to reduce the risk of post-POEM reflux, researchers have also pioneered procedures to mimic surgical fundoplication. The POEM + fundoplication (POEM+F) procedure, was first reported in 2019. It involved anterior myotomy, followed by an anterior partial fundoplication using endoscopic clips and detachable loop. The same group subsequently modified the technique by using a novel endoscopic needle holder device. A recent single-center study reporting results of 25 POEM+F procedures in India also confirmed its reproducibility and safety, as well as a reasonably low incidence of reflux.
A recently developed endoscopic tacking device, X-TackTM (Apollo EndoSurgery, Inc, United States), allows approximation of tissue with the use of a helix tacking system connected to a suture. It could be applied for closure of defect after endoscopic resection. The novel device may also potentially be used for the endoscopic fundoplication by approximating the anterior fundus to the edge of esophageal myotomy during POEM+F. The simple design of the device could make the fundoplication easier and less time consuming. The investigators designed this pilot study to confirm the feasibility of using X-TackTM for POEM+F in patients with achalasia.
- Conditions
- Achalasia
- Being tested
- POEM + F
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POEM + FProcedure or surgery
POEM would first be performed as per usual technique. Upon completion of the myotomy, a 2cm incision would be created over the adventitial layer at the level of gastro-esophageal junction (GEJ), allowing scope entry into the peritoneal cavity. The anterior part of the gastric fundus would be located, grasped with endoscopic forceps and pulled towards the esophageal myotomy site. The intended anterior fundus would then be anchored to the edge of the muscle at the GEJ, with the use of X-TackTM system. After confirming adequate hemostasis and secure anchorage of fundus to the esophagus, the mucosal entry site for the submucosal tunnel would be closed with endoscopic clips as per usual POEM technique.
| Study group | Role | What they receive |
|---|---|---|
| POEM + F arm | Experimental | This arm will receive the POEM + F procedure Receives: Procedure: POEM + F |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
Percentage of successful myotomy plus anchorage of gastric fundus to the esophagus by X-TackTM system, without major intra-operative complication.
Measured: 1 day
Secondary outcomes (4)
Clinical success
defined as Eckardt score ≤3
Measured: 1 year
Incidence of symptomatic reflux
Incidence (percentage) of patients with postoperative symptomatic reflux
Measured: 1 year
Incidence of endoscopic esophagitis
Incidence (Percentage) of endoscopic esophagitis, graded according to Los Angeles classification
Measured: 1 year
Adverse events of procedure
Incidence (Percentage) of adverse events related to POEM + F
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 posted28 Jan 2022
- Study start24 Mar 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AchalasiaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Model description
- Per-oral endoscopic Myotomy with fundoplication (POEM + F)
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hon Chi Yip, Chinese University of Hong Kong
- Investigators
- Hon Chi Yip, FRCSEd, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214443
- Sponsor's protocol ID
- CRE 2021.648
- Status last verified
- Sep 2023
- First submitted
- 15 Jan 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Per-oral Endoscopic Myotomy With Fundoplication (POEM+F) for Achalasia - a Pilot Study
- ClinicalTrials.gov ID
- NCT05214443
- Acronym / sponsor ID
- CRE 2021.648
- Conditions
- Achalasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 28 Jan 2022 (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.
This is a pilot study to investigate the feasibility of performing per-oral endoscopic Myotomy (POEM) with endoscopic fundoplication for patient with achalasia. Post-POEM reflux is a well documented adverse event after POEM for achalasia. Case series have been published by addition of endoscopic fundoplication procedure during POEM. In the current study, 10 patients would be recruited for investigating the novel POEM procedure with fundoplication by using a new X-tack anchoring device.
Detailed description
Since the first published case series, per-oral endoscopic myotomy (POEM) has emerged as one of the standard treatment options for achalasia. The procedure offers a scarless endoscopic alternative to conventional surgical myotomy. In a recent randomized controlled trial, POEM was found to achieve similar treatment success rate when compared with surgical myotomy. POEM was also found to have reduced serious adverse events. When compared with endoscopic pneumatic dilatation, POEM was demonstrated to have a significantly higher clinical success rate.
One of the major limitations of POEM was the higher incidence of post-procedural acid reflux. During surgical myotomy, a partial fundoplication would routinely be performed to reinforce the gastro-esophageal junction, and such procedure has been proven to reduce post-operative reflux. Multiple studies have confirmed the higher incidence of endoscopic reflux esophagitis and proton pump requirements after POEM than surgical myotomy, including the aforementioned randomized trial.
Modification and standardization of the POEM techniques were proposed to reduce the incidence of reflux esophagitis. Limitation of gastric myotomy length to below 2cm was found to be a useful maneuver. Identification of the two penetrating vessels at cardia may help to correctly measure the length of gastric myotomy, together with the use of double scope technique.
In an attempt to reduce the risk of post-POEM reflux, researchers have also pioneered procedures to mimic surgical fundoplication. The POEM + fundoplication (POEM+F) procedure, was first reported in 2019. It involved anterior myotomy, followed by an anterior partial fundoplication using endoscopic clips and detachable loop. The same group subsequently modified the technique by using a novel endoscopic needle holder device. A recent single-center study reporting results of 25 POEM+F procedures in India also confirmed its reproducibility and safety, as well as a reasonably low incidence of reflux.
A recently developed endoscopic tacking device, X-TackTM (Apollo EndoSurgery, Inc, United States), allows approximation of tissue with the use of a helix tacking system connected to a suture. It could be applied for closure of defect after endoscopic resection. The novel device may also potentially be used for the endoscopic fundoplication by approximating the anterior fundus to the edge of esophageal myotomy during POEM+F. The simple design of the device could make the fundoplication easier and less time consuming. The investigators designed this pilot study to confirm the feasibility of using X-TackTM for POEM+F in patients with achalasia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Per-oral endoscopic Myotomy with fundoplication (POEM + F)
| Arm | Type | Receives |
|---|---|---|
| POEM + F arm | Experimental | Procedure: POEM + FThis arm will receive the POEM + F procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
Key exclusion criteria (4 listed)
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 |
|---|---|---|
| POEM + FPOEM would first be performed as per usual technique. Upon completion of the myotomy, a 2cm incision would be created over the adventitial layer at the level of gastro-esophageal junction (GEJ), allowing scope entry into the peritoneal cavity. The anterior part of the gastric fundus would be located, grasped with endoscopic forceps and pulled towards the esophageal myotomy site. The intended anterior fundus would then be anchored to the edge of the muscle at the GEJ, with the use of X-TackTM system. After confirming adequate hemostasis and secure anchorage of fundus to the esophagus, the mucosal entry site for the submucosal tunnel would be closed with endoscopic clips as per usual POEM technique. | Procedure or surgery | POEM + F arm |
Primary outcome
Technical success
Time frame: 1 day
Percentage of successful myotomy plus anchorage of gastric fundus to the esophagus by X-TackTM system, without major intra-operative complication.
4 secondary outcomes
Clinical success
Time frame: 1 year
Incidence of symptomatic reflux
Time frame: 1 year
Incidence of endoscopic esophagitis
Time frame: 1 year
Adverse events of procedure
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 7 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Hon Chi Yip, FRCSEd principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POEM + F in people with Achalasia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 2 inclusion and 4 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 7 Sep 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 Hong Kong. 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?
Contact Hon Chi Yip, FRCSEd (35052627, hcyip@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success (time frame: 1 day). 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 7 Sep 2023.