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Is Botulinum Toxin Injection of the Pylorus During Ivor–Lewis Esophagogastrectomy the Optimal Drainage Strategy?

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Is Botulinum Toxin Injection of the Pylorus During Ivor–Lewis Esophagogastrectomy the Optimal Drainage Strategy? GENERAL THORACIC SURGERY Is botulinum toxin injection of the pylorus during Ivor–Lewis esophagogastrectomy the optimal drainage strategy? Robert James Cerfolio, MD, FACS, FCCP,a Ayesha S. Bryant, MSPH, MD,b Cheri L. Canon, MD,c Roopa Dhawan, BS,d and Mohamad A. Eloubeidi, MDe Background: The optimal management of the pylorus during esophagogastrectomy is unknown. Pyloromyotomy and pyloroplasty cause early edema and risk long-term bile reflux; however, the lack of pyloric drainage might risk early aspiration. Methods: We performed a retrospective study with a prospective database on patients with esophageal cancer or high-grade dysplasia who underwent Ivor–Lewis esophagogastrectomy. All had one surgeon and similar stomach tubularization, hand-sewn anastomoses, nasogastric tube duration, and postoperative prokinetic agents. Out- comes of postoperative gastric emptying, aspiration, and swallowing symptoms were compared. Results: Between January 1997 and June 2008, there were 221 patients. Seventy-one patients had a pyloromyot- omy, and gastric emptying judged on postoperative day 4 was delayed in 93% (52% had any morbidity and 14% had respiratory morbidity). Fifty-four patients had no drainage procedure, and gastric emptying was delayed in 96% (59% had any morbidity and 22% had respiratory morbidity). Twenty-eight patients underwent pyloro- GTS plasty, and 96% had delayed gastric emptying (50% had any morbidity and 32% had respiratory morbidity). Sixty-eight patients had botulinum toxin injection into the pylorus. Gastric emptying was delayed in only 59% (P ¼ .002, 44% had any morbidity and 13% had respiratory morbidity). Hospital length of stay (P ¼ .015) and operative times (P ¼ .037) were shorter in the botulinum toxin group. Follow-up (mean, 40 months) showed symptoms of biliary reflux to be lowest in the botulinum toxin group (P ¼ .024). Conclusion: Injection of the pylorus with botulinum toxin at the time of esophagogastrectomy is safe and de- creases operative time when compared with pyloroplasty or pyloromyotomy. In addition, it can improve early gastric emptying, decrease respiratory complications, shorten hospital stay, and reduce late bile reflux. A prospec- tive multi-institutional randomized trial is needed. Although esophagectomy for cancer is a well-established op- often prolongs gastric emptying in the early postoperative pe- eration, there exists much controversy as to the optimal surgi- riod when the patient is at the highest risk of aspiration. In ad- cal approach and management of the pylorus. Many who dition, it can lead to long-term bile reflux, for which there is no prefer pyloroplasty argue that it helps gastric emptying associ- satisfactory treatment. Conversely, if the pylorus is left alone ated with pyloric denervated and hence reduces the risk of so as to avoid long-term bile reflux, the stomach often does not pulmonary aspiration.1,2 However, it renders the pylorus empty well initially, and hence the risk of aspiration remains incompetent and risks life-long bile reflux after esophagogas- increased. Aspiration and aspiration pneumonia are the most trectomy. In contrast, it has been argued that other techniques, common and devastating early postoperative complications such as pyloromyotomy or even no-pyloric-drainage proce- after esophagogastrectomy3,4 and have remained a vexing dures, are preferred. We have practiced all 3 techniques and problem in our practice. For these reasons, we postulated have found that none are ideal. Although a pyloromyotomy that the intraoperative injection of Botulinum A 100 U toxin and pyloroplasty help the vagectomized and denervated stom- (Allergan Pharmaceuticals, Westport, Ireland), or what is ach empty, there is often edema after this procedure, and this more commonly called Botox, at the time of esophagogastrec- tomy might represent a promising solution to this controver- sial but clinically important dilemma. Botox can promote From the Section of Thoracic Surgery, Division of Cardio-Thoracic Surgery, Depart- ment of Surgerya; the Division of Cardio-thoracic Surgery, Department of Surgeryb; gastric empting for a few months after surgical intervention, the Department of Radiologyc; the University of Alabama School of Medicined; and thereby reducing the risk of aspiration when it is most likely e the Division of Gastroenterology, Department of Medicine, University of Alabama and most lethal, but it should not cause long-term bile reflux at Birmingham, Birmingham, Ala. Read at the Thirty-fourth Annual Meeting of the Western Thoracic Surgical Associa- because its effects dissipate within a few months. We evalu- tion, Kona, Hawaii, June 25–28, 2008. ated our preliminary experience using Botox injection into Received for publication June 23, 2008; revisions received Aug 7, 2008; accepted for the pylorus at the time of esophagogastrectomy. publication Aug 30, 2008. Address for reprints: Robert J. Cerfolio, MD, FACS, FCCP, Division of Cardiotho- racic Surgery, University of Alabama at Birmingham, 703 19th St S, ZRB 739, Bir- mingham, AL 35294 (E-mail: [email protected]). MATERIALS AND METHODS J Thorac Cardiovasc Surg 2009;137:565-72 This is a retrospective cohort study of a prospective database of a con- 0022-5223/$36.00 secutive series of patients with distal or midesophageal cancer or those Copyright Ó 2009 by The American Association for Thoracic Surgery with high-grade dysplasia who underwent Ivor–Lewis esophagogastrec- doi:10.1016/j.jtcvs.2008.08.049 tomy performed by one surgeon in an academic setting (the University The Journal of Thoracic and Cardiovascular Surgery c Volume 137, Number 3 565 General Thoracic Surgery Cerfolio et al of Alabama at Birmingham, Birmingham, Ala). All patients had their TABLE 1. Definitions of gastric emptying on postoperative day 4 stomachs tubularized in the same fashion. The fundus of the stomach, swallow study the gastroesophageal junction, and the proximal portion of the lesser curve Category Descriptor Definition Level were all removed with a stapling device. This staple line was then over- sewn. The conduit’s width was approximately 6 cm in all patients, and 1 None Prompt emptying, usually<2 min 1 the anastomosis was constructed through an end of the esophagus to the 2 Slight Majority of emptying (>90%) in 2–5 min 2 side of the stomach. The conduit was constructed so as not to be redundant, 3 Mild Majority of emptying (>90%)in to sit straight in the posterior mediastinal bed, and to have approximately 3 6–10 min cm of stomach above the anastomosis. A standard Ivor–Lewis esophago- 4 Moderate Slow emptying over a period of 10 3 gastrectomy was performed,5 and a hand-sewn anastomosis of the end minutes, usually 25% to 90% emptied of the esophagus to the side of the stomach above the azygous vein was in 10 min constructed in all patients. Patients younger than 19 years of age or those who underwent esophagogastrectomy for reasons other than dysplasia or 5 Significant Little to no emptying, almost all contrast malignancy were excluded. In addition, patients who underwent a transhia- remaining at 10 min tal or 3-hole6 esophagogastrectomy or a total esophagectomy with gastric pull-up with a gastric–pharyngeal anastomosis were also excluded from GTS this study to decrease the effect that the location of the anastomosis or remaining amount of native esophagus might have on emptying. Early Table 1. Level 1 indicated no delay and included only patients with category outcomes assessed and compared were operative times, morbidity rates, 1 emptying. Level 2 included patients with category 2 or 3 emptying, and operative mortality, gastric emptying, incidence of anastomotic leak, and level 3 included patients with category 4 or 5 emptying. This study and hospital length of stay. Late outcomes included the incidence of bile reflux the prospective database were both approved by the University of Alabama symptoms, as assessed by survey, and stricture rates, as assessed based on at Birmingham’s Institutional Review Board. Patient contest was obtained the need for anastomotic dilation. Clinically significant bile reflux was as- for entry into the prospective database but was waived for this study. sessed at the time of the 3-week postoperative clinic visit; at 3, 6, and 9 months; and yearly thereafter by telephone. The specific questions used Statistical Analysis to identify bile reflux were the patient’s reporting of nausea, vomiting after c2 or while eating, and/or the sensation of bland liquid regurgitating cranially, Data were analyzed by using the Student t test and Wilcoxon and tests, pillow staining of dark material during sleep, or both. as appropriate. A stepwise multivariate logistic regression model was used For the purposes of this study, aspiration was defined as a patient with to correct for the effect of multiple variables and their interactions for delay altered eating habits or choking and/or coughing symptoms while swallow- of gastric emptying. Variables that were associated with gastric emptying ing, clinical assessment consistent with aspiration in which medical inter- delay with a P value of less than .1 in the univariate analysis were entered vention was indicated (eg, urgent intubation, followed by bronchoscopy, into the multivariate model. Software used was SAS version 9.1 (SAS Insti- antibiotics, oxygen, and suction), or both. Pneumonia was defined as radio- tute, Inc, Cary, NC). graphic findings of an infiltrate with an increased white blood cell count and a fever along with clinical manifestation of respiratory distress (dyspnea,
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