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GastroparesisNCT03679104

Endoscopic Clips Versus Overstich Suturing System Device for Closure of Mucosotomy After G-POEM

A study testing Closure of mucosotomy using endoscopic clips and Closure of mucosotomy using OverStitch™ suturing device in people with Gastroparesis, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Gastric per-oral endoscopic pyloromyotomy (G-POEM) has been assessed as new modality for treatment of refractory gastroparesis. G-POEM is promising method, which is still under investigation as its safety and efficacy has not been established yet. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Gastroparesis
What is being tested?
Closure of mucosotomy using endoscopic clips and Closure of mucosotomy using OverStitch™ suturing device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteCzechia
Study dates
1 Nov 2018to 26 Jan 2021
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

  • Refractory (> 6 months) and severe (based on a validated total Gastroparesis Cardinal Symptom Index) gastroparesis, with confirmed gastric emptying based on a gastric emptying study: standardized protocol of scintigraphy in all patients (performed less than 6 months prior to enrolment). The total GSCI (Gastroparesis Cardinal Symptom Index) score must be >2.0
  • Abnormal gastric emptying is defined as retention of Tc-99 m >60% at 2 h and/or ≥10% of residual activity at 4 h on a standardized sulphur colloid solid-phase gastric emptying study.
  • Abnormal gastric emptying breath test based on a solid normal range determination for the test used (e.g. T1/2 > 109 min)
  • Severe refractory disease is defined as GCSI >2.0 and failure or recurrence in patients who received available optimal pharmacological therapies.
  • Persons 18 years or older at the time of signing the informed consent
  • Signed informed consent

Who cannot join

  • No previous attempt with at least one prokinetic drug
  • No previous attempt to withdraw anticholinergic agents and glucagon like peptide -1 (GLP-1) and amylin analogues in patients treated with these substances
  • Active treatment with opioids or a history of treatment with opioids within 12 months before enrolment
  • Previous gastric surgery (Billroth I or Billroth II)
  • Known eosinophilic gastroenteritis
  • Organic pyloric (or intestinal) obstruction (fibrotic stricture, etc.)
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  • Sever coagulopathy
  • Oesophageal or gastric varices and /or portal gastropathy
  • Advanced liver cirrhosis (Child B or Child C)
  • Active peptic ulcer disease
  • Pregnancy or puerperium
  • Malignant or pre-malignant gastric diseases (dysplasia, gastric cancer, GIST): patients with a history of such disease after its cure are eligible for enrolment
  • Any other condition, which in the opinion of the investigator would interfere with study requirements
  • Uncontrolled diabetes mellitus
  • Diagnosis of rumination syndrome or "eating" disorder (mental anorexia, bulimia nervosa)
  • Inability to obtain informed consent

Trial locations and contacts

1 site in 1 country.

Czechia1 site

  • Institute for Clinical and Experimental Medicine

    Prague, Prague, 14021

Other trials in Czechia

About this study

Official title: Endoscopic Clips Versus Overstich Suturing System Device for Closure of Mucosotomy After Per-oral Endoscopic Pyloromyotomy (G-POEM)

Gastric per-oral endoscopic pyloromyotomy (G-POEM) has been assessed as new modality for treatment of refractory gastroparesis. G-POEM is promising method, which is still under investigation as its safety and efficacy has not been established yet. The ideal closure technique in patients undergoing G-POEM needs to be established. Several techniques may be used for endoscopic mucosal closure: endoscopic clips, OTSC (over the scope clips), endo-loop based methods (KING closure) or endoscopic suture.

The aim of this prospective, open-label study is to compare efficacy and safety of two methods for incision closure in patients who undergo G-POEM: endoscopic clips vs. endoscopic suturing system (OverStitch).

Read the detailed description

Based on principles of NOTES (natural orifice transluminal endoscopic surgery), a mini-invasive therapeutic procedure such as per-oral endoscopic myotomy (POEM) or gastric per-oral endoscopic pyloromyotomy (G-POEM) have been assessed as new modalities for treatment of oesophageal achalasia or refractory gastroparesis. G-POEM is a new and promising method, which is still under investigation as its safety and efficacy has not been established yet. There are several questions, which need to be answered before G-POEM is considered as a standard clinical procedure. These questions concern, among others, efficacy, safety, technical performance etc. Mucosal incision should be endoscopically closed to prevent leakage into the abdominal cavity. Obtaining adequate mucosal closure is one of the most important steps of the procedure and is essential in avoiding major morbidity. The ideal closure technique in patients undergoing G-POEM needs to be established. Several techniques may be used for endoscopic mucosal closure: endoscopic clips, OTSC clips, endo-loop based methods (KING closure) or endoscopic suture. At present, simple closure with endoscopic clips has been the most frequently described method for mucosal closure in patients undergoing G-POEM. However, as gastric mucosa is thicker compared to the esophagus, where clips are used for POEM without any major problems, several authors have described problems during gastric incision closure - it takes a rather longer time, some clips cannot be placed and in some patients, other closure method had to be used. Thus, endoscopic clips may not be an ideal closure method in the stomach. A platform that replicates a principle of surgical suturing is endoscopic suturing system.

The aim of this prospective, open-label study is to compare efficacy and safety of two methods for incision closure in patients who undergo G-POEM: endoscopic clips vs. endoscopic suturing system (OverStitch).

Investigators plan to randomize 30-40 patients (15-20 in both arms, ratio 1:1).

The assigned closure method will be decided by an endoscopist prior to starting closure.

Conditions
Gastroparesis
Being tested
Closure of mucosotomy using endoscopic clips, Closure of mucosotomy using OverStitch™ suturing device
Keywords
Gastric Per-oral Endoscopic Pyloromyotomy
Medical subject headings
Gastroparesis

What participants receive

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

  • Closure of mucosotomy using endoscopic clipsProcedure or surgery

    Gastric per-oral endoscopic pyloromyotomy procedure requires the incision in the mucosa and submucosa. The closure of this incision at the end of the procedure will be done using endoscopic clips. These are used in endoscopy to mechanically close two mucosal surfaces without the need for surgery and suturing. In this study, the following endoclips may be used: Resolution 360™ Clip (Boston Scientific), QuickClip Pro™(Olympus) or Instinct™ Endoscopic Hemoclip (Cook Medical).

  • Closure of mucosotomy using OverStitch™ suturing deviceProcedure or surgery

    Gastric per-oral endoscopic pyloromyotomy procedure requires the incision in the mucosa and submucosa. The closure of this incision at the end of the procedure will be done by OverStitch™ (Apollo Endosurgery Inc., Austin, Texas, USA), which is a suturing device that enables advanced endoscopic surgery by allowing physicians to place full-thickness sutures through a flexible endoscope.

Study groups in NCT03679104
Study groupRoleWhat they receive
Endoscopic clipsActive comparatorClosure of mucosotomy using endoscopic clips
Receives: Procedure: Closure of mucosotomy using endoscopic clips
OverStitch™ suturing deviceActive comparatorClosure of mucosotomy using OverStitch™ suturing device
Receives: Procedure: Closure of mucosotomy using OverStitch™ suturing device

What is being measured

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

  1. Proportion of subjects with successful and safe incision closure.

    Definition of successful closure: endoscopically completely closed incision, no need to use another "rescue" closure method, no leak on post-operative day 1, no leak related complications, no readmission due to closure dehiscence, no need for surgery due to closure.

    Measured: 3 months

Secondary outcomes (6)

  1. Easiness of the closure

    Handling with endoclips or OverStitch will be evaluated by means of a questionnaire where ease of use was scored on a VAS (visual analogue scale), 0 = impossible, 10 = very easy) by both, endoscopist as well as an endoscopy nurse assisting with the closure procedure.

    Measured: 3 months

  2. Closure time of mucosotomy

    The duration of endoscopic closure, reported by the endoscopist performing the procedure

    Measured: 1 day

  3. Cost

    To evaluate the economics and cost-effectiveness of treating gastroparesis

    Measured: 3 months

  4. Healing quality

    Assessing gastric scar after gastric per-oral pyloromyotomy: based on a visual examination, the healing process could include three stages, namely stage A (active stage): means no tissue reparation features, stage H (healing stage): early morphological reparation features, and stage S (scar stage): completed repair process, that could by described as S1 (red) or S2 (white). Width and length of scar will be measures as well.

    Measured: 3 months

  5. Readmission within 30 days

    A readmission for an endoscopic or surgery intervention to address a complication resulting from care during the initial admission.

    Measured: 30 days

  6. Mortality at 3 months

    Incidence of fatal complications related to procedure

    Measured: 3 months

Timeline

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

  1. First posted20 Sep 2018
  2. Study start1 Nov 2018
  3. Primary completion1 Dec 2020
  4. Study completion26 Jan 2021

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
Randomised
Intervention model
Crossover
Model description
Patients will be allocated to the corresponding group according to a peri-procedural finding, availability of a respective closure method and endoscopist´s decision.
Masking
Single blind
Who is masked
Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03679104
Sponsor's protocol ID
IClinicalEM3
Status last verified
Jan 2021
First submitted
12 Aug 2018
Last updated
27 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Khashab MA, Ngamruengphong S, Carr-Locke D, Bapaye A, Benias PC, Serouya S, Dorwat S, Chaves DM, Artifon E, de Moura EG, Kumbhari V, Chavez YH, Bukhari M, Hajiyeva G, Ismail A, Chen YI, Chung H. Gastric per-oral endoscopic myotomy for refractory gastroparesis: results from the first multicenter study on endoscopic pyloromyotomy (with video). Gastrointest Endosc. 2017 Jan;85(1):123-128. doi: 10.1016/j.gie.2016.06.048. Epub 2016 Jun 25.

    PubMed 27354102

  • Dacha S, Mekaroonkamol P, Li L, Shahnavaz N, Sakaria S, Keilin S, Willingham F, Christie J, Cai Q. Outcomes and quality-of-life assessment after gastric per-oral endoscopic pyloromyotomy (with video). Gastrointest Endosc. 2017 Aug;86(2):282-289. doi: 10.1016/j.gie.2017.01.031. Epub 2017 Feb 1.

    PubMed 28161449

  • Paspatis GA, Dumonceau JM, Barthet M, Meisner S, Repici A, Saunders BP, Vezakis A, Gonzalez JM, Turino SY, Tsiamoulos ZP, Fockens P, Hassan C. Diagnosis and management of iatrogenic endoscopic perforations: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy. 2014 Aug;46(8):693-711. doi: 10.1055/s-0034-1377531. Epub 2014 Jul 21.

    PubMed 25046348

  • Kantsevoy SV, Bitner M, Mitrakov AA, Thuluvath PJ. Endoscopic suturing closure of large mucosal defects after endoscopic submucosal dissection is technically feasible, fast, and eliminates the need for hospitalization (with videos). Gastrointest Endosc. 2014 Mar;79(3):503-7. doi: 10.1016/j.gie.2013.10.051. Epub 2013 Dec 12.

    PubMed 24332082

  • Crichton NJ. Principles of statistical analysis in nursing and healthcare research. Nurse Res. 2001 Oct 1;9(1):4-16. doi: 10.7748/nr2001.10.9.1.4.c6171.

    PubMed 26954377

Questions about this trial

What is this clinical trial studying?

A study testing Closure of mucosotomy using endoscopic clips and Closure of mucosotomy using OverStitch™ suturing device in people with Gastroparesis, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.

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 6 inclusion and 16 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: finished, as of the sponsor's last update on 27 Jan 2021. 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 Czechia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Proportion of subjects with successful and safe incision closure. (time frame: 3 months). 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 NCT03679104, which also lists 5 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 27 Jan 2021.

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