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Gastroesophageal Reflux DiseaseNCT06153901

Endoloop Mediated Cardioplication to Treat Gastroesophageal Reflux Disease

A study testing endoloop mediated cardioplication (ECLC) procedure in people with Gastroesophageal Reflux Disease, run by Qilu Hospital of Shandong University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Endoscopic full-thickness plication (EFTP) of cardia/fundus has been shown effective in treating GERD patients. However, EFTP requires proprietary equipment that are not available in many countries. Here, we designed a metal clip and endoloop mediated cardioplication (ECLC) procedure to achieve EFTP. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Gastroesophageal Reflux Disease
What is being tested?
endoloop mediated cardioplication (ECLC) procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
No sites listed yet
Study dates
10 Dec 2023to 10 Dec 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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age 18-60 years old
  • hiatal hernia ≤ 3cm
  • Sliding hernia ≤ 3cm
  • Classic reflux symptoms (heartburn, reflux) lasting for more than 6 months
  • Daily PPIs ≥ 6 months
  • Esophagitis (Los Angeles grade) Grade A, B, and C
Show all 12Show fewer
  • Gastroesophageal valve I-III grade (Hill grade)
  • Pathological esophageal acid exposure (percentage of time with 24-hour esophageal PH<4 <4.2%)
  • Normal or near normal esophageal movement (through manometry or impedance)
  • The lower esophageal sphincter pressure (LESP) is between 5-15mmHg
  • DeMeester score ≥ 14.7 or total reflux episodes>73
  • Patients who sign an informed consent form and voluntarily accept surgical expenses.

Who cannot join

  • BMI>35kg/m2
  • ASA >II
  • Barrett's esophagus
  • Hill IV level
  • Large esophageal hiatal hernia>3cm
  • Esophagitis (Los Angeles grade) Grade D
Show all 13Show fewer
  • Peptic ulcer
  • Primary esophageal motility disorders such as achalasia
  • Previous esophageal or gastric surgery
  • Uncontrolled systemic diseases
  • Pregnancy or planned pregnancy within 1 year
  • Have a history of cervical fusion surgery, esophageal diverticulum, scleroderma or dermatomyositis, eosinophilic esophagitis, liver cirrhosis or coagulation dysfunction, immune system diseases
  • Patients deemed unsuitable for inclusion by researchers.

About this study

Official title: Metal Clip and Endoloop Mediated Endoscopic Cardioplication (ECLC) for the Treatment of Gastroesophageal Reflux Disease (GERD):a Prospective Cohort Study

Endoscopic full-thickness plication (EFTP) of cardia/fundus has been shown effective in treating GERD patients. However, EFTP requires proprietary equipment that are not available in many countries. Here, we designed a metal clip and endoloop mediated cardioplication (ECLC) procedure to achieve EFTP.

Read the detailed description

Endoscopic full thickness pancreatography (EFTP) is a minimally invasive surgical method that has emerged in recent years for the treatment of severe gastroesophageal reflux disease. This surgery requires the use of disposable patented instruments, which is expensive and has not entered the domestic market. To this end, we have innovatively developed an endoloop mediated cardioplication (ECLC) that only requires metal clips and nylon ropes. The most common and inexpensive endoscopic consumables can achieve the effect of tightening the lower esophageal sphincter, which is expected to be used for the treatment of gastroesophageal reflux disease. The ECLC surgery first incises the mucosa and submucosa on the small curvature side and posterior side (approximately 3/4 of the total circumference) of the diaphragm level cardia until smooth muscle fibers are exposed; Fix the metal clip covered with nylon rope on the exposed smooth muscle layer, and finally tighten the nylon rope to achieve full folding of the cardia. After the surgery, the patient fasted overnight and received intravenous PPI treatment. On the second day after surgery, a fluid diet was restored and discharge was possible. ECLC is simple, easy to operate, relatively inexpensive, and minimally invasive, and is expected to become a new method for treating severe gastroesophageal reflux disease.

Being tested
endoloop mediated cardioplication (ECLC) procedure
Keywords
Gastroesophageal Reflux Disease, Endoscopy Upper GI Tract, anti-reflux, Endoscopic therapy
Medical subject headings
Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • endoloop mediated cardioplication (ECLC) procedureProcedure or surgery

    The ECLC surgery first incises the mucosa and submucosa on the small curvature side and posterior side (approximately 3/4 of the total circumference) of the diaphragm level cardia until smooth muscle fibers are exposed; Fix the metal clip covered with nylon rope on the exposed smooth muscle layer, and finally tighten the nylon rope to achieve full folding of the cardia. After the surgery, the patient fasted overnight and received intravenous PPI treatment. On the second day after surgery, a fluid diet was restored and discharge was possible. ECLC is simple, easy to operate, relatively inexpensive, and minimally invasive, and is expected to become a new method for treating severe gastroesophageal reflux disease.

Study groups in NCT06153901
Study groupRoleWhat they receive
endoloop mediated cardioplication (ECLC)ExperimentalThe ECLC surgery first incises the mucosa and submucosa on the small curvature side and posterior side (approximately 3/4 of the total circumference) of the diaphragm level cardia until smooth muscle fibers are exposed; Fix the metal clip covered with nylon rope on the exposed smooth muscle layer, and finally tighten the nylon rope to achieve full folding of the cardia. After the surgery, the patient fasted overnight and received intravenous PPI treatment. On the second day after surgery, a fluid diet was restored and discharge was possible. ECLC is simple, easy to operate, relatively inexpensive, and minimally invasive, and is expected to become a new method for treating severe gastroesophageal reflux disease.
Receives: Procedure: endoloop mediated cardioplication (ECLC) procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The total score of the GERD-HRQL questionnaire

    Questionnaire (GERD-HRQL) : Total Score: Calculated by summing the individual scores toquestions 1-15 Greatest possible score ( worst symptoms)= 75 Lowest possible score ( no symptoms)= 0 Heartburn Score: Calculated by summing the individual scores to questions 1-6 . Worst heartburn symptoms = 30 No heartburn symptoms= 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate heartburn elimination. Regurgitation Score: Calculated by summing the individual scores to questions10-15. Worst regurgitation symptoms = 30 No regurgitation symptoms = 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate regurgitation elimination.

    Measured: at 3 month follow- up

Secondary outcomes (6)

  1. PPI usage

    Requirement of PPI for control of symptoms at 3, 6 and 12 months Heartburn and Regurgitation questionnaire 0 =No symptom 1 =Symptoms noticeablebut not bothersome 2=S ymptoms noticeableand bothersome but noteve ry day 3 =Symptoms bothersome every day 4 =Symptoms affect daily activity 5 =Symptoms are incapacitating to do daily activities

    Measured: at 3, 6 and 12 month follow- up

  2. Total score of GERD GerdQ questionnaire

    Questionnaire (GERD-GerdQ ) : Recall the frequency of burning sensation (heartburn) after your sternum in the past 7 days;How often do you feel stomach contents (liquid or food) returning to your throat or mouth (reflux) in the past 7 days?How often did you feel pain in the center of your upper abdomen in the past 7 days?How often did you feel nauseous in the past 7 days?How often have you had difficulty getting good night sleep due to heartburn and/or reflux in the past 7 days? Looking back on the past 7 days, in addition to the medication advised by the doctor, did you take additional medication to alleviate the frequency of heartburn and/or reflux? (such as calcium carbonate, aluminum hydroxide, and other antacids).0 days are 0 points, 1 day is 1 point, 2-3 days are 2 points, and 4-7 days are 3 points. Add up the scores for each item to obtain the total score.

    Measured: at 3 month follow- up

  3. Total score of GERD GerdQ and GERD HRQL questionnaires

    as mentioned above

    Measured: at 6 and 12 month follow- up

  4. Esophageal acid reflux and DeMeester score

    There are three monitoring indicators: (1) Total acid exposure time: percentage of total time with pH<4 in 24 hours, standing and lying positions; (2) Acid exposure frequency: number of times with pH<4; (3) Duration of acid exposure: number of times with reflux duration ≥ 5 minutes and maximum reflux duration. The above indicators were calculated using the Demester system of the computer to obtain the total score. Foreign data suggests a normal value of<14.72, while limited domestic data suggests a value of<12.4. The normal 24-hour esophageal pH reference value is: the total time for pH<4 is<4%, the number of reflux times within 5 minutes is ≤ 2, and the longest reflux duration is<16 minutes.

    Measured: at 3, 6, and 12 months follow- up

  5. Healing status of reflux esophagitis and damaged mucosa

    Repair of esophageal mucosa at the surgical site

    Measured: at 3, 6, and 12 months

  6. Safety evaluation indicators

    The incidence of intraoperative and postoperative bleeding and perforation; Postoperative pain score

    Measured: at 0, 3, 6, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2023
  2. Study start10 Dec 2023 (estimated)
  3. Primary completion10 Dec 2024 (estimated)
  4. Study completion10 Dec 2024 (estimated)

Resources

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
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06153901
Sponsor's protocol ID
2023-QILU-LU 02
Status last verified
Nov 2023
First submitted
22 Nov 2023
Last updated
1 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing endoloop mediated cardioplication (ECLC) procedure in people with Gastroesophageal Reflux Disease, run by Qilu Hospital of Shandong University.

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 12 inclusion and 13 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 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

The total score of the GERD-HRQL questionnaire (time frame: at 3 month follow- up). 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 NCT06153901.

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 1 Dec 2023.

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