Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
ID06721520

Comparative Effectiveness of Intrapyloric Botulinum Toxin Injection Versus Pyloromyotomy for Pyloric Drainage During Esophagectomy A Registry-Based Pragmatic Randomized Noninferiority Trial

Led by The Cleveland Clinic · Updated on 2026-02-25

170

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating two methods to help drain the stomach during esophagectomy surgery in patients with benign or malignant esophageal diseases. The study compares the use of intrapyloric botulinum toxin (Botox) injection versus pyloromyotomy to see if Botox is not worse than pyloromyotomy in preventing delayed gastric emptying symptoms six months after surgery. This trial is a randomized, pragmatic, registry-based clinical study conducted at a single institution. Participants will be randomly assigned during surgery to receive either the Botox injection or pyloromyotomy. For Botox, 100 units dissolved in saline are injected into four areas of the pyloric muscle. For pyloromyotomy, a surgical incision is made in the pyloric muscle to allow better emptying. Both procedures occur after the pylorus is identified during esophagectomy. The study includes two treatment arms with equal allocation. Participants will complete surveys assessing digestive symptoms at 3 months, 6 months, 1 year, and 2 years after surgery. A gastric emptying scan will be performed at 6 months to measure stomach emptying. Researchers will monitor symptoms using the Gastroparesis Cardinal Symptom Index (GCSI) and other questionnaires, track complications within 30 days, and record any pyloric reinterventions up to 24 months. The study aims to follow patients long term to assess outcomes and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Undergoing elective esophagectomy (thoracoabdominal, Ivor-Lewis, McKeown)
  • Receiving a gastric conduit for alimentary reconstruction
  • Technically able to receive either intrapyloric Botox injection or pyloromyotomy as determined during surgery
  • Willing and able to provide informed consent
  • Willing and able to participate in long-term follow up including study visits and surveys
Not Eligible

You will not qualify if you...

  • Undergoing emergent esophagectomy (e.g., for esophageal perforation)
  • Having underlying neuromuscular diseases such as amyotrophic lateral sclerosis, myasthenia gravis, muscular dystrophies, or Lambert-Eaton syndrome
  • Undergoing left thoracoabdominal esophagectomy without left cervical neck incision (Sweet esophagectomy)
  • Pregnancy
  • Allergy or hypersensitivity to botulinum toxin
  • Unable to feasibly receive both pyloric interventions due to technical reasons (e.g., central obesity making pyloromyotomy difficult)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to 30 days post-operatively or until discharge from the index hospitalization, whichever is longer

Participants undergo esophagectomy with either intrapyloric Botox injection or pyloromyotomy during surgery. Immediate post-operative care follows the surgery.

1 surgical procedure and inpatient post-operative care

Post-operative Follow-up

Duration - Up to 24 months post-operatively

Participants are monitored with follow-up visits and assessments including symptom questionnaires and gastric emptying studies to evaluate recovery and treatment effectiveness.

Follow-up visits at 6 months and additional visits as needed up to 24 months

Trial Site Locations

Total: 1 location

1

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

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Research Team

A

Andrew Conner, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Pyloric drainage (pyloroplasty) or no drainage in gastric reconstruction after esophagectomy: a meta-analysis of randomized controlled trials.

John D Urschel, Chris J Blewett, J Edward M Young...

https://pubmed.ncbi.nlm.nih.gov/12119515

Effect of intraoperative botulinum toxin injection on delayed gastric emptying and need for endoscopic pyloric intervention following esophagectomy: a systematic review, meta-analysis, and meta-regression analysis.

Shahab Hajibandeh, Shahin Hajibandeh, Matthew McKenna...

https://pubmed.ncbi.nlm.nih.gov/37539558