Esophageal NeoplasmNCT05736705
Monopolar and Bipolar in Esophageal ESD
A study testing Endoscopic Submucosal Dissection and Bipolar electrocautery knife in people with Esophageal Neoplasm and Esophageal Polyp, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The objective of this study is to prospectively document the efficacy and clinical outcomes of Endoscopic Submucosal Dissection procedure that utilize either a novel Bipolar-Current ESD device or the standard monopolar electrocautery knife. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Esophageal Neoplasm, Esophageal Polyp, Endoscopic Submucosal Dissection
- What is being tested?
- Endoscopic Submucosal Dissection and Bipolar electrocautery knife
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2023to 25 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is ≥ 18 years old
- Patient is capable of providing informed consent
- Patient is referred for ESD procedure of an esophageal neoplastic lesion
Who cannot join
- Patient is < 18 years old
- Patient refused and/or unable to provide consent
- Patient is a pregnant woman
- Patients with lesions removed with other techniques besides ESD (i.e. cap EMR) or a modified ESD technique
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Comparing Outcomes of Monopolar Current Cutting Knife and Bipolar RFA Knife in Esophageal Endoscopic Submucosal Dissection
The objective of this study is to prospectively document the efficacy and clinical outcomes of Endoscopic Submucosal Dissection procedure that utilize either a novel Bipolar-Current ESD device or the standard monopolar electrocautery knife.
Read the detailed description
Endoscopic submucosal dissection (ESD) is a novel technique for the removal of esophageal lesions or polyps with high-risk features. ESD is minimally invasive and allows the removal of esophageal polyps without resorting to morbid surgery. The process of ESD includes marking the lesions selected for removal, followed by submucosal injection of a lifting agent, then circumferential incisions using a specialized knife followed by submucosal dissection of the entire lesion.
Traditionally, knifes utilizing monopolar current such as dual knife or hybrid knife were the preferred tools for endoscopic submucosal dissection. These knifes allows accurate dissection and excellent hemostasis. However, due to monopolar current generated heat, post coagulation syndrome can be seen in up to 8 to 40 % of patients. Post coagulation syndrome present with pain, fever and leukocytosis and requires supportive treatment with IV fluid and antibiotics. In addition, for large esophageal lesions, stricturing can occur after resection due to significant scar formation induced by large amounts of energy. Almost all patients with 60% of the esophageal circumference removed via monopolar knives, will develop an esophageal stricture at some point. These patients require serial esophageal dilations, and although easily managed, its development can be quite troublesome to the patient. Nevertheless, ESD is still the preferred modality for removal of these lesions, since it avoids the need for morbid surgery. Recently, a novel bipolar RFA knife were approved by FDA for the performance of ESD. The knife utilizes bipolar RFA current for submucosal dissection which can potentially expedite submucosal dissection and decrease the rates of post polypectomy syndrome and scar formation, by using significantly less energy. This bipolar knife may allow for removal of large esophageal lesions without causing major esophageal stricturing.
Our tertiary referral center Baylor St Luke's Medical Center is a center of excellence for ESD procedure and the investigators have previously reported our Esophageal ESD experience using the monopolar current knife. The goal of our protocol is to compare the performance of monopolar current cutting knife and bipolar RFA knife in esophageal endoscopic submucosal dissection.
- Conditions
- Esophageal Neoplasm, Esophageal Polyp, Endoscopic Submucosal Dissection, Bipolar Electocautery
- Being tested
- Endoscopic Submucosal Dissection, Bipolar electrocautery knife
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Submucosal DissectionProcedure or surgery
Also called ESD, Mucosal Resection
Participants randomized in this arm will have the removal of their esophageal lesion utilizing the monopolar electrocautery knife.
Bipolar electrocautery knifeDevice
Also called ESD, Mucosal Resection
Participants randomized in this arm will have the removal of their esophageal lesion utilizing the bipolar electrocautery knife.
| Study group | Role | What they receive |
|---|---|---|
| Monopolar Electrocautery tool | Active comparator | Patients randomized into this group will receive the standard of care monopolar tool for their endoscopic submucosal dissection procedure. Receives: Procedure: Endoscopic Submucosal Dissection |
| Bipolar Electrocautery tool | Experimental | Patients randomized into this group will receive the standard of care bipolar tool for their endoscopic submucosal dissection procedure. Receives: Procedure: Endoscopic Submucosal Dissection; Device: Bipolar electrocautery knife |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speed of Endoscopic Submucosal Dissection
The speed of endoscopic submucosal dissection as calculated by cm2/hour
Measured: Day 1 (procedure day)
Secondary outcomes (5)
En-bloc resection achieved
Endoscopist removal of entire tissue specimen as a whole
Measured: Day 1 (procedure day)
R0 Resection achieved
Margins of tissue specimen deemed by pathologist as completely excised (R0)
Measured: 1-3 days post-procedure
Curative Resection achieved
Complete removal of diseased tissue by endoscopic submucosal dissection procedure
Measured: 1-3 days post-procedure
Adverse events
Collection of unanticipated medical occurrences within a 12 month time frame
Measured: 1 month, 3 months, 6 months, 12 months
Rate of esophageal stricturing post-procedure
Calculated as a percentage of patients reported with stricturing with 1-3 days following procedure.
Measured: 1-3 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start23 Jan 2023
- Primary completion25 Jun 2024
- Study completion25 Jun 2024
Why it stopped: Study being withdrawn as it is re-written now as a prospective study. Please reference new study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups with patients randomized into receiving either the standard of care monopolar electrocautery tool or bipolar electrocautery tool.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salmaan Azam Jawaid, MD, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736705
- Sponsor's protocol ID
- H-52921
- Status last verified
- Jun 2024
- First submitted
- 13 Feb 2023
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Outcomes of Monopolar Current Cutting Knife and Bipolar RFA Knife in Esophageal Endoscopic Submucosal Dissection
- ClinicalTrials.gov ID
- NCT05736705
- Acronym / sponsor ID
- H-52921
- Conditions
- Esophageal Neoplasm, Esophageal Polyp, Endoscopic Submucosal Dissection, Bipolar Electocautery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study being withdrawn as it is re-written now as a prospective study. Please reference new study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 21 Feb 2023 (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.
The objective of this study is to prospectively document the efficacy and clinical outcomes of Endoscopic Submucosal Dissection procedure that utilize either a novel Bipolar-Current ESD device or the standard monopolar electrocautery knife.
Detailed description
Endoscopic submucosal dissection (ESD) is a novel technique for the removal of esophageal lesions or polyps with high-risk features. ESD is minimally invasive and allows the removal of esophageal polyps without resorting to morbid surgery. The process of ESD includes marking the lesions selected for removal, followed by submucosal injection of a lifting agent, then circumferential incisions using a specialized knife followed by submucosal dissection of the entire lesion.
Traditionally, knifes utilizing monopolar current such as dual knife or hybrid knife were the preferred tools for endoscopic submucosal dissection. These knifes allows accurate dissection and excellent hemostasis. However, due to monopolar current generated heat, post coagulation syndrome can be seen in up to 8 to 40 % of patients. Post coagulation syndrome present with pain, fever and leukocytosis and requires supportive treatment with IV fluid and antibiotics. In addition, for large esophageal lesions, stricturing can occur after resection due to significant scar formation induced by large amounts of energy. Almost all patients with 60% of the esophageal circumference removed via monopolar knives, will develop an esophageal stricture at some point. These patients require serial esophageal dilations, and although easily managed, its development can be quite troublesome to the patient. Nevertheless, ESD is still the preferred modality for removal of these lesions, since it avoids the need for morbid surgery. Recently, a novel bipolar RFA knife were approved by FDA for the performance of ESD. The knife utilizes bipolar RFA current for submucosal dissection which can potentially expedite submucosal dissection and decrease the rates of post polypectomy syndrome and scar formation, by using significantly less energy. This bipolar knife may allow for removal of large esophageal lesions without causing major esophageal stricturing.
Our tertiary referral center Baylor St Luke's Medical Center is a center of excellence for ESD procedure and the investigators have previously reported our Esophageal ESD experience using the monopolar current knife. The goal of our protocol is to compare the performance of monopolar current cutting knife and bipolar RFA knife in esophageal endoscopic submucosal dissection.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two groups with patients randomized into receiving either the standard of care monopolar electrocautery tool or bipolar electrocautery tool.
| Arm | Type | Receives |
|---|---|---|
| Monopolar Electrocautery tool | Active comparator | Procedure: Endoscopic Submucosal DissectionPatients randomized into this group will receive the standard of care monopolar tool for their endoscopic submucosal dissection procedure. |
| Bipolar Electrocautery tool | Experimental | Procedure: Endoscopic Submucosal Dissection, Device: Bipolar electrocautery knifePatients randomized into this group will receive the standard of care bipolar tool for their endoscopic submucosal dissection procedure. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is ≥ 18 years old
- Patient is capable of providing informed consent
- Patient is referred for ESD procedure of an esophageal neoplastic lesion
Key exclusion criteria (4 listed)
- Patient is < 18 years old
- Patient refused and/or unable to provide consent
- Patient is a pregnant woman
- Patients with lesions removed with other techniques besides ESD (i.e. cap EMR) or a modified ESD technique
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 Submucosal DissectionAlso: ESD, Mucosal ResectionParticipants randomized in this arm will have the removal of their esophageal lesion utilizing the monopolar electrocautery knife. | Procedure or surgery | Bipolar Electrocautery tool, Monopolar Electrocautery tool |
| Bipolar electrocautery knifeAlso: ESD, Mucosal ResectionParticipants randomized in this arm will have the removal of their esophageal lesion utilizing the bipolar electrocautery knife. | Device | Bipolar Electrocautery tool |
Primary outcome
Speed of Endoscopic Submucosal Dissection
Time frame: Day 1 (procedure day)
The speed of endoscopic submucosal dissection as calculated by cm2/hour
5 secondary outcomes
En-bloc resection achieved
Time frame: Day 1 (procedure day)
R0 Resection achieved
Time frame: 1-3 days post-procedure
Curative Resection achieved
Time frame: 1-3 days post-procedure
Adverse events
Time frame: 1 month, 3 months, 6 months, 12 months
Rate of esophageal stricturing post-procedure
Time frame: 1-3 days post-procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Submucosal Dissection and Bipolar electrocautery knife in people with Esophageal Neoplasm and Esophageal Polyp, run by Baylor College of Medicine 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 3 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: withdrawn, as of the sponsor's last update on 27 Jun 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Speed of Endoscopic Submucosal Dissection (time frame: Day 1 (procedure 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 27 Jun 2024.