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NCT06721520 · ClinicalTrials.gov registry record · Phase 2

Effectiveness of Methods for Pyloric Drainage in esophagecTomY: Botox vs. Pyloromyotomy

A Phase 2 study of Esophagectomy and Esophageal Diseases, sponsored by The Cleveland Clinic.

Recruiting
Registry status
Phase 2
Development phase
170
Enrollment target
1
Study location

NCT06721520: Recruiting Phase 2 study of Esophagectomy and Esophageal Diseases, sponsored by The Cleveland Clinic.

NCT06721520 is a Phase 2 study of Esophagectomy and Esophageal Diseases that is actively recruiting participants, run by The Cleveland Clinic. The registered enrollment target is 170 participants, below the 2,114-participant average among 7 other Esophagectomy trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06721520, a Phase 2 study of Esophagectomy and Esophageal Diseases, is actively recruiting participants, sponsored by The Cleveland Clinic.

RECRUITING
Registry status
Phase 2
Development phase
170 participants
Enrollment target
1
Study location

Study Summary

The goal of this pragmatic, registry-based, randomized clinical trial is to find out if using botulinum toxin (Botox) to help drain the stomach during an esophagectomy works as well as a pyloromyotomy in patients undergoing elective esophagectomy for benign or malignant esophageal disease. Both methods are intended to prevent problems with food emptying too slowly from the stomach (delayed gastric emptying), which can cause discomfort after surgery. The main question it aims to answer is: Is intrapyloric Botox injection as a drainage procedure during esophagectomy non-inferior in preventing symptoms of delayed gastric emptying at 6 months postoperatively compared to pyloromyotomy? Researchers will compare intrapyloric Botox injection to pyloromyotomy to see if Botox is non-inferior to pyloromyotomy in easing symptoms of delayed gastric emptying. Participants will: Be randomized to one of two treatment groups-either intrapyloric Botox injection or pyloromyotomy-during their esophagectomy. Complete surveys assessing digestive symptoms at standard postoperative follow-up intervals (3 months, 6 months, 1 year, and 2 years postoperatively). Undergo a standard gastric emptying study at 6 months after surgery.

Primary Outcome

The GCSI is a validated 9-item instrument used to quantify severity of symptoms associated with delayed gastric emptying. The GCSI is based on three subscales, which measure cardinal symptoms related to delayed gastric emptying: postprandial fullness/early satiety (4 items), nausea/vomiting (3 items), and bloating (2 items). A 6-point Likert-type response scale, ranging from 0 (none) to 5 (very severe) is used for rating the severity of each symptom item, with a recall period of 2 weeks. Subscal

Conditions Studied

Esophagectomy Esophageal Diseases Delayed Gastric Emptying Following Procedure Esophageal Achalasia Esophageal Cancer Surgery Pylorus Dysfunction Esophageal Dysmotility

Interventions

  • BIOLOGICAL Botulinum Toxin A (Botox )
  • PROCEDURE Pyloromyotomy

Study Locations (1)

Ohio

  • Cleveland Clinic - Cleveland

Trial Details

FieldValue
Enrollment Target 170 participants
Start Date 2024-12-03
Est. Completion 2028-05-31
Phase Phase 2
The Cleveland Clinic

688 total trials

What NCT06721520 shows while recruiting

NCT06721520 is an interventional study that assigns participants to a tested intervention. The registered 170 participants enrollment target is mid-sized for trials with a published cap, below the 2,114-participant average among 7 other Esophagectomy trials with a reported enrollment target (92% lower).

The record links to 7 conditions, with Esophagectomy appearing as the primary indexed condition, and to 2 interventions - of which Botulinum Toxin A (Botox ) is the first listed.

NCT06721520 reports a single indexed study location in Ohio.

Frequently Asked Questions

What is clinical trial NCT06721520 about?

NCT06721520 is a clinical study titled "Effectiveness of Methods for Pyloric Drainage in esophagecTomY: Botox vs. Pyloromyotomy". The goal of this pragmatic, registry-based, randomized clinical trial is to find out if using botulinum toxin (Botox) to help drain the stomach during an esophagectomy works as well as a pyloromyotomy in patients undergoing elective esophagectomy for benign or malignant esophageal disease. Both meth...

What is the current status of trial NCT06721520?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 170 participants. The study started on 2024-12-03. Estimated completion is 2028-05-31.

What conditions does trial NCT06721520 study?

This clinical trial studies the following conditions: Esophagectomy, Esophageal Diseases, Delayed Gastric Emptying Following Procedure, Esophageal Achalasia, Esophageal Cancer Surgery.

What interventions are being tested in trial NCT06721520?

The interventions under investigation include: Botulinum Toxin A (Botox ) (BIOLOGICAL), Pyloromyotomy (PROCEDURE).

Who is sponsoring clinical trial NCT06721520?

This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06721520 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT06721520

Source: ClinicalTrials.gov NCT06721520, the US trial registry maintained by the National Library of Medicine. NCT06721520 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.