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

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. Subscale scores are calculated by averaging across the item scores within each subscale. The range of subscale scores is 0 to 5, where higher scores reflect perception of worse symptom severity. The GCSI total score is constructed as the average of the three symptom subscales scores. GCSI. GSCI scores will be obtained preoperatively and at 3-month, 6-month, 1-year, and 2-year follow up, with 6 months as the specific time point for our primary endpoint.

Perioperative complications include gastroesophageal anastomotic leaks, pyloric leaks, aspiration, pneumonia, respiratory failure, cardiac arrhythmia, myocardial infarction, cardiac failure, mortality, and readmission within 30 days for nausea/vomiting or pneumonia. These outcomes are routinely recorded by trained registry personnel at our institution as part of national quality reporting requirements.

At 6 months postoperatively, a 4-hour solid-phase GES, considered the gold standard for assessing gastric motility, will be obtained as per our institute's standard of care and interpreted by Cleveland Clinic radiologists. The study consists of administering a low-fat, egg-white meal containing technetium-99m sulfur colloid labeled egg albumin. Gastric retention of the egg meal is measured at baseline and at 1, 2, and 4 hours after consumption and the results are reported as a retained percentage. Also included in the radiology report is the half-emptying time, or the time the stomach requires to empty 50% of the ingested radiolabeled test solid meal, which is commonly used to assess gastric emptying in post-esophagectomy studies. Due to the non-linear nature of gastric emptying, we will also use the percentage of food retained at 4 hours as an additional measure, which has been a marker of delayed gastric emptying in previous research.

The impact of symptom severity on patient quality of life (QoL) will be assessed by Cleveland Clinic Esophageal Questionnaire (CEQ) raw domain scores. The CEQ is a validated patient-reported outcome measure that allows for quantification of esophageal symptoms and their impact on the patient's quality of life. The CEQ is comprised of 34 items divided into 6 domains: dysphagia (7 items), eating (7 items), pain (5 items), reflux/regurgitation (5 items), dyspepsia (4 items), and dumping (6 items). Each item is accompanied by a question regarding frequency of symptoms, with a 6-point Likert-type response option ranging from 1 (never) to 6 (several times a day) and a question regarding the symptom's impact on quality of life, with a 5-point Likert-type response option ranging from 1 (not at all) to 5 (a lot). We will obtain the raw scores across each domain at baseline preoperatively and at 3-months, 6-months, 1-year, and 2-years follow-up, per our institution's standard of care protocol.

After esophagectomy, patients reporting severe symptoms related to delayed gastric emptying, determined based upon standard clinical evaluation (i.e., patients with a moderate or large amount of retained food on routine, post-operative upper endoscopy after fasting for 8 hours and reporting severe regurgitation or having an aspiration pneumonia event), will be offered further endoscopic treatment of their delayed gastric emptying, per our institute's standard of care protocol. We will compare frequency of reinterventions up until 24-months postoperatively in each arm. Per our institution's protocol, all of these patients, regardless of which treatment arm they are in, initially receive endoscopic Botox injection. If their gastric emptying improves, demonstrated by improvement of GCSI score or decrease in amount of retained food on upper endoscopy, and they do not have symptoms of dumping syndrome, they are then offered gastric per-oral endoscopic pyloromyotomy (G-POEM).