Clinical trial NCT06721520: Effectiveness of Methods for Pyloric Drainage in esophagecTomY: Botox vs. Pyloromyotomy
Official title: Comparative Effectiveness of Intrapyloric Botulinum Toxin Injection Versus Pyloromyotomy for Pyloric Drainage During Esophagectomy: A Registry-Based, Pragmatic Randomized Noninferiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Esophageal Cancer Surgery
Esophagectomy
Delayed Gastric Emptying Following Procedure
Esophageal Diseases
Esophageal Achalasia
Pylorus Dysfunction
Esophageal Dysmotility
Keywords: Esophagectomy
Delayed gastric emptying
Delayed conduit emptying
Botox
botulinum toxin
Pyloromyotomy
Pyloric drainage
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: This is a single institution, pragmatic, registry-based, prospective, single-blinded, randomized, double-arm, noninferiority clinical trial comparing outcomes of two standard-of-care alternative intraoperative methods of pyloric drainage during esophagectomy. One arm of the study will be patients receiving intervention 1, intrapyloric Botox injection (Botox Group), and the other arm will be patients receiving intervention 2, pyloromyotomy (Pyloromyotomy Group). Participants will be allocated equally to the interventions being compared (allocation ratio 1:1).

Patients randomized for intrapyloric Botox injection will undergo our standard procedure as follows: 100 units of Botox is dissolved in 10 mL normal saline. After identifying the pylorus during esophagectomy, 10 mL of the Botox solution is injected intramuscularly at the anterior pyloric ring in 2 separate areas and in 1 area on each side of the pyloric ring (total 4 areas). Patients randomized for pyloromyotomy will undergo standard pyloromyotomy through a transabdominal, anterior approach.

This study will occur at Cleveland Clinic Foundation in Cleveland, OH. Three staff surgeons will perform these operations.

Eligibility criteria: Inclusion Criteria:

* 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 ultimately determined intraoperatively
* Willing and able to provide informed consent
* Willing and able to participate in long-term follow up including study visits and surveys

Exclusion Criteria:

* Undergoing emergent esophagectomy (e.g., for esophageal perforation)
* Patients with underlying neuromuscular disease as Botox would be contraindicated (amyotrophic lateral sclerosis, myasthenia gravis, muscular dystrophies, Lambert-Eaton syndrome)
* Patients undergoing left thoracoabdominal without left cervical neck incision (i.e., Sweet esophagectomy) - excluded due to the extent of gastric resection
* Pregnancy
* Allergy or hypersensitivity to botulinum toxin
* Cannot feasibly receive both pyloric interventions as determined intraoperatively (e.g., patients with central obesity undergoing thoracoabdominal esophagectomy makes for a technically difficult pyloromyotomy)

Primary outcomes:
measure: Gastroparesis Cardinal Symptom Index (GCSI) total score at 6 months postoperatively or prior to the first reintervention (which ever comes first)
timeFrame: 6 months postoperatively or prior to the first pyloric reintervention to treat symptoms of delayed gastric emptying postoperatively (whichever comes first)
Secondary outcomes:
measure: Complications in the immediate post-operative period (within 30 days post-operatively)
timeFrame: 30 days postoperatively or until discharge from the index hospitalization (whichever duration is greater)
measure: Gastric emptying at 6 months postoperatively, measured by gastric emptying scintigraphy study (GES)
timeFrame: 6 months postoperatively
measure: Cleveland Clinic Esophageal Questionnaire (CEQ) domain scores at 6-months postoperatively or prior to the first reintervention (whichever comes first)
timeFrame: 6 months postoperatively or prior to the first pyloric reintervention to treat symptoms of delayed gastric emptying postoperatively (whichever comes first)
measure: Pyloric reinterventions by 24 months post-operatively
timeFrame: 24 months postoperatively
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Siva Raja, MD
role: PRINCIPAL_INVESTIGATOR
References:
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