Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04770441
Status:
COMPLETED
Last Update Posted:
2023-08-18
First Post:
2021-02-22
Brief Title:
Transoral Incisionless Fundoplication in Post-POEM GERD
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Prospective Evaluation of the Use of TIF Transoral Incisionless Fundoplication to Treat Post-poem GERD
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
POEM per oral endoscopic myotomy is effective for the treatment of swallowing disorders but can induce acid reflux If acid reflux remains untreated in this situation it can lead to significant problems Thus minimizing abnormal acid exposure after POEM is very important Typically this is done with acid suppression medications such as Prilosec or Nexium However long term acid suppression medication has been linked to possible long-term complications Transoral incisionless fundoplication TIF has been approved for the treatment of reflux but its use in reflux after POEM has not been investigated in detail We hypothesize TIF will be able to decrease the amount of acid reflux in to the esophagus thereby allowing patients to remain off of acid suppression medications
Once enrolled into the study you will undergo the POEM procedure 3 months after the procedure we will assess for abnormal reflux via questionnaires and diagnostic testing as part of the standard management post POEM If there is evidence of abnormal reflux the TIF procedure will be performed 3 months after the TIF you will have similar testing again to document resolution in abnormal acid refluxYou will be followed for 12 months as part of the study If at the 3 month mark there is no evidence of abnormal reflux you will neither be placed on PPI nor undergo TIF and will be followed for 12 months to assess for abnormal reflux
Once enrolled into the study you will undergo the POEM procedure 3 months after the procedure we will assess for abnormal reflux via questionnaires and diagnostic testing as part of the standard management post POEM If there is evidence of abnormal reflux the TIF procedure will be performed 3 months after the TIF you will have similar testing again to document resolution in abnormal acid refluxYou will be followed for 12 months as part of the study If at the 3 month mark there is no evidence of abnormal reflux you will neither be placed on PPI nor undergo TIF and will be followed for 12 months to assess for abnormal reflux
Detailed Description:
EGD esophagogastroduodenoscopy is a safe procedure used extensively to evaluate the esophagus stomach and small intestine With the assistance of the anesthesiology team we will put you to sleep partially to minimize discomfort during the insertion of the endoscopy This is normally how this procedure is performed and deemed very safe Potential complications include breathing problems holes in the intestine and bleeding These occur very infrequently In our study EGD will be used at three checkpoints all of which are part of standard of care
1 at the time of POEM to rule out other unusual structural abnormalities
2 at 3 months during measurement of acid exposure in the esophagus via Bravo pH
3 3 months after TIF placement 6 months after enrollment and POEM to document resolution in acid reflux
Esophageal manometry is a non-endoscopic procedure that involves using a safe numbing cream to allow passage of the manometry catheter from the nose down to the end of the esophagus Different measurements are taken from the catheter and the catheter is then removed This is a standard of care procedure in the evaluation of patients with esophageal motilityswallowing disorders It will be used in the following settings and all are part of standard of care
1 3 months after POEM as part of standard of care to assess improvement in the swallowing
2 3 months after TIF 6 months post POEM only if swallowing issues reappear
Bravo pH study is used to assess abnormal acid reflux and is considered gold standard in identifying the degree of acid reflux It is standard of care for this procedure to be performed in patients with suspected acid reflux and post-POEM to assess need for long term acid suppression It involves performing an endoscopy first followed by deployment and implantation of the Bravo pH capsule into the end of the esophagus Risks include bleeding injury to the esophagus or dislodgment of the capsule However these are rare instances
POEM Those enrolled into the study will undergo a diagnostic endoscopy at the same allotted time as the POEM It will be explained to you in detail but involves endoscopically cutting the muscle at the end of the esophagus called a myotomy It is less invasive than its surgical equivalent Hellers myotomy but equally effective Two endoscopist one with extensive experience in POEM and the other with formal training in POEM will be performing the actual POEM procedures
TIF The TIF procedure is performed using the FDA approved EsophyX-Z device EndoGastricSolutions Redmond Wash USA It has been shown to be effective in the management of acid reflux in patients who fail acid suppression therapy or in patients who would like to avoid long term acid suppression with acid suppression therapy due to the potential side effects It involves the use of a flexible suturing apparatus that fits over the endoscope and is used to create an artificial wrap around the end of the esophagus thereby mimicking the effects of the typical surgical wrap In the right setting it is as effective as its surgical counterpart but less invasive Due to the incisionless approach patients undergoing TIF experience less discomfort and faster recovery than those undergoing traditional anti-reflux surgery
1 at the time of POEM to rule out other unusual structural abnormalities
2 at 3 months during measurement of acid exposure in the esophagus via Bravo pH
3 3 months after TIF placement 6 months after enrollment and POEM to document resolution in acid reflux
Esophageal manometry is a non-endoscopic procedure that involves using a safe numbing cream to allow passage of the manometry catheter from the nose down to the end of the esophagus Different measurements are taken from the catheter and the catheter is then removed This is a standard of care procedure in the evaluation of patients with esophageal motilityswallowing disorders It will be used in the following settings and all are part of standard of care
1 3 months after POEM as part of standard of care to assess improvement in the swallowing
2 3 months after TIF 6 months post POEM only if swallowing issues reappear
Bravo pH study is used to assess abnormal acid reflux and is considered gold standard in identifying the degree of acid reflux It is standard of care for this procedure to be performed in patients with suspected acid reflux and post-POEM to assess need for long term acid suppression It involves performing an endoscopy first followed by deployment and implantation of the Bravo pH capsule into the end of the esophagus Risks include bleeding injury to the esophagus or dislodgment of the capsule However these are rare instances
POEM Those enrolled into the study will undergo a diagnostic endoscopy at the same allotted time as the POEM It will be explained to you in detail but involves endoscopically cutting the muscle at the end of the esophagus called a myotomy It is less invasive than its surgical equivalent Hellers myotomy but equally effective Two endoscopist one with extensive experience in POEM and the other with formal training in POEM will be performing the actual POEM procedures
TIF The TIF procedure is performed using the FDA approved EsophyX-Z device EndoGastricSolutions Redmond Wash USA It has been shown to be effective in the management of acid reflux in patients who fail acid suppression therapy or in patients who would like to avoid long term acid suppression with acid suppression therapy due to the potential side effects It involves the use of a flexible suturing apparatus that fits over the endoscope and is used to create an artificial wrap around the end of the esophagus thereby mimicking the effects of the typical surgical wrap In the right setting it is as effective as its surgical counterpart but less invasive Due to the incisionless approach patients undergoing TIF experience less discomfort and faster recovery than those undergoing traditional anti-reflux surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None