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

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

170

Participants

Timeline

Start Date

December 3, 2024

Primary Completion Date

December 31, 2027

Study Completion Date

May 31, 2028

Conditions
Esophageal Cancer SurgeryEsophagectomyDelayed Gastric Emptying Following ProcedureEsophageal DiseasesEsophageal AchalasiaPylorus DysfunctionEsophageal Dysmotility
Interventions
BIOLOGICAL

Botulinum Toxin A (Botox )

Patients randomized for intrapyloric Botox injection will undergo the following standard procedure: 100 units of Botox are dissolved in 10 mL normal saline. After identifying the pylorus, the 10 mL of 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.

PROCEDURE

Pyloromyotomy

Patients randomized for pyloromyotomy will undergo standard pyloromyotomy as follows: after identifying the pylorus, a 2-cm longitudinal incision is made with Metzenbaum or Mayo scissors on the anterior pylorus, centered on the pyloric ring. The incision extends through the serosa and muscular layers to expose the submucosa and mucosa, which is left intact. The cut muscle is spread apart until the submucosa bulges up to the level of the cut serosa. Care is taken to avoid perforation, and the surgeon confirms no mucosal perforation at the end of the procedure. If a perforation is encountered, it will be repaired primarily.

Trial Locations (1)

44195

RECRUITING

Cleveland Clinic, Cleveland

All Listed Sponsors
lead

The Cleveland Clinic

OTHER