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

NCT03679104 | Completed DMC

• 1 other identifier: IClinicalEM3
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Gastroparesis

Keywords

Gastric Per-oral Endoscopic Pyloromyotomy

Outcome Measures

Primary Outcomes (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.

  3 months

Secondary Outcomes (6)

• Easiness of the closure

  3 months

• Closure time of mucosotomy

  1 day

• Cost

  3 months

• Healing quality

  3 months

• Readmission within 30 days

  30 days

Study Arms (2)

Endoscopic clips

ACTIVE COMPARATOR

Closure of mucosotomy using endoscopic clips

Procedure: Closure of mucosotomy using endoscopic clips

OverStitch™ suturing device

ACTIVE COMPARATOR

Closure of mucosotomy using OverStitch™ suturing device

Procedure: Closure of mucosotomy using OverStitch™ suturing device

Interventions

Closure of mucosotomy using endoscopic clips PROCEDURE

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).

Endoscopic clips

Closure of mucosotomy using OverStitch™ suturing device PROCEDURE

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.

OverStitch™ suturing device

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)
• 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)

Sponsors & Collaborators

• Institute for Clinical and Experimental Medicine: lead

Study Sites (1)

Institute for Clinical and Experimental Medicine

Prague, Prague, 14021, Czechia

Location

Related Publications (5)

• 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.

  PMID: 27354102 RESULT

• 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.

  PMID: 28161449 RESULT

• 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.

  PMID: 25046348 RESULT

• 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.

  PMID: 24332082 RESULT

• 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.

  PMID: 26954377 RESULT

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan Martinek

  Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic

  STUDY CHAIR

• Rastislav Hustak

  Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic

  PRINCIPAL INVESTIGATOR

• Zuzana Vackova

  Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic

  PRINCIPAL INVESTIGATOR

• Tomas Hucl

  Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic

  PRINCIPAL INVESTIGATOR

• Jan Usak

  Universitary hospital Trnava, Slovak Republic

  PRINCIPAL INVESTIGATOR

• Julius Spicak, Prof

  Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. prof.

Model Details: Patients will be allocated to the corresponding group according to a peri-procedural finding, availability of a respective closure method and endoscopist´s decision.

Study Record Dates

• First Submitted: August 12, 2018
• First Posted: September 20, 2018
• Study Start: November 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: January 26, 2021
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

CZ (1)