Fast-Track Esophagectomy Protocol for Esophageal Cancer
Fast-Track Esophagectomy Protocol for Esophageal Cancer
In our study, we demonstrated that a fast-track setup significantly reduced LOS and technical hospital charges as well as the incidence of pulmonary complications without affecting rates of hospital readmission and 30- and 90-day mortality. Taken together, our findings show that the institution of the FTEP was safe and reduced hospital charges.
In the face of escalating health care costs, reducing patients' length of postoperative stay and number of postoperative complications is key to using medical resources optimally. Despite major advancements in the perioperative management of esophageal cancer patients, esophagectomy remains significantly associated with high incidences of mortality and morbidity. Over the last decade, fast-track protocols have been used successfully for several surgical specialties as well as for esophagectomy. In 1998, Brodner et al conducted a retrospective cohort study that showed that a multimodal approach can be used to enhance recovery after esophagectomy. In 2003, Chandrashekar et al, who suggested that patients could be safely transferred to and managed on a high-dependency unit following immediate extubation after 2-stage esophagectomy, were the first to mention an FTEP. In 2004, Cerfolio et al were the first to publish a study of a fast-track protocol for esophagectomy. Later retrospective cohort studies showed that FTEP was associated with reduced LOS. A recent single-institution, randomized clinical trial also showed that an enhanced recovery protocol for esophagectomy resulted in a small but significant reduction in LOS.
Detailed descriptions of the clinical care pathways of the traditional esophagectomy protocol and the FTEP used at our institution are given in Table 3. As part of the FTEP, patients were immediately extubated after surgery, transferred to the postanesthesia care unit only for a few hours, and then transferred to the telemetry unit. However, 7% of patients on FTEP still went to ICU because these were high-risk salvage esophageal resection patients who had other comorbidities that required ventilator support immediately after surgery. In the telemetry unit, the patients' vital signs, chest tube output, and urine output were monitored hourly, and the patients were allowed to ambulate within 4 hours of their arrival to the floor. Early ambulation reduces postoperative stress and fatigue and facilitates recovery. The reduced LOS could be attributed to close monitoring and keeping patients ambulatory in the telemetry unit.
Perioperative fluid therapy plays an important role in the care of patients after esophagectomy. Patients on an FTEP are typically recommended to receive a balanced rather than restrictive regimen of preoperative fluid therapy as well as epidural analgesia for postoperative pain management. In our study, there was not much difference in perioperative fluid therapy and postoperative pain management between patients on the traditional esophagectomy protocol and those on the FTEP. For perioperative fluid therapy, patients on the traditional esophagectomy protocol as well as those on the FTEP received 5% dextrose in half the amount of normal saline (0.45% w/v of sodium chloride) at a rate of 125 mL/h on the day of surgery and postoperative day (POD) 1 and POD 2. After POD 2, the volume of fluid administered was reduced gradually, from 125 mL/h on POD 3 to 75 mL/h on POD 4, 50 mL/h on POD 5, 21 mL/h on POD 6, and finally to saline lock on POD 7. For their postoperative pain, patients received epidural analgesia with 5 μg/mL hydromorphone administered with 0.075% bupivacaine at a rate of 10 mL/h continuously, with patient boluses of 3 mL administered every 10 minutes and clinician boluses of 5 mL administered every 3 hours as needed. This pain management regimen was continued for a maximum of 7 days or stopped early if the patient's chest tubes were removed before that time. The proportion of patients who were discharged on J-tube feeding without barium swallow in the FTEP group (65%) was significantly larger than that in the traditional protocol group (31%; P < 0.001). For patients on the FTEP, a barium swallow was performed between 10 and 15 days after discharge on an outpatient basis and the J-tube was removed 4 to 6 weeks after discharge, whenever the patient could take in most of the calories by mouth. Although J-tube feeding has been found to be a safe and effective method of providing postoperative nutritional support, it has not been part of the FTEPs other studies have investigated. Thus, additional studies to investigate the use of J-tube feeding in this setting are warranted. Also, no additional outpatient care was required for fast-track patients over the standard pathway. We had a standard follow-up for all esophagectomy patients. First follow-up was done at 6 weeks after discharge, next 3 follow-ups were done every 6 months, and later a yearly follow-up was done.
Patients' baseline characteristics such as age and comorbidities including diabetes, COPD, and coronary artery disease are significant predictors of morbidity and mortality after esophagectomy. In our study, groups A and B had similar proportions of patients with these predictors. In terms of perioperative treatment, the proportion of patients who received neoadjuvant chemoradiotherapy in group B (85%) was higher than that in group A (73%). One meta-analysis showed that, compared with surgery alone, neoadjuvant chemoradiotherapy plus surgery is associated with a higher risk of mortality. With regard to tumor characteristics, the patients in group B had larger, more clinically advanced tumors than the patients in group A did. Although these characteristics put patients in group B at a higher risk of poor outcomes, these patients had better outcomes than the patients in group A did even after adjustment for these predictors in the multivariable analysis.
One recent trend in localized esophageal carcinoma surgery is MIE, which utilizes a combined thoracoscopic and laparoscopic approach or a hybrid approach. Systematic reviews comparing MIE with conventional methods of open surgery (ie, transthoracic and transhiatal esophagectomy) found MIE to be safe and associated with better postoperative outcomes. In this study, MIE was not part of the FTEP. Given that MIE is a recent development, the proportion of patients who underwent MIE in group B was unsurprisingly higher than that in group A. Multivariable analysis revealed MIE to be associated with pulmonary complications but not LOS.
The anastomotic leak rate (14% in group A vs 13% in group B, P = 0.581) seems high because leaks were calculated including clinically nonsignificant leaks, which required no intervention (Table 5). Anastomotic leak was classified as grade 1, small contained leak in barium or CT requiring no intervention or basic treatment, such as giving antibiotic, or observation; grade 2, small contained leak requiring minimum intervention, such as stent or drainage placement; grade 3, leak requiring a repeat operation; and grade 4, conduit loss requiring conduit resection (Table 5). For patients who had an anastomotic leak, the mean LOS increased by 2 days but there was no difference in 30 days perioperative mortality (2.1% in leak group vs 2.9% in no leak group, P = 1.000).
Our study, which included patients treated on a traditional esophagectomy protocol during a 4-year period immediately before the institution of an FTEP as well as patients treated on an FTEP during its first 4 years of implementation, enabled us to thoroughly assess postoperative outcomes in a large group of patients over a long period. Owing to the introduction of an FTEP in March 2008, we reduced the proportion of patients who were immediately transferred to the SICU after esophagectomy from 71% in March 2004 to just 7% in March 2012 (Table 5). Ours is one of the first studies conducted in the United States to assess the impact of an FTEP on hospital charges. In our study, there was about 17% reduction in the median technical charges and 31% reduction in the mean technical charges after institution of an FTEP. The reduction in hospital charges can be contributed to decreased SICU days, LOS, and postoperative complication rate in group B patients. This suggested that an FTEP reduced hospital charges without compromising the safety of the patients.
Our study had a few potential limitations. Although we assessed important outcomes such as patient safety and LOS, we did not assess patients' satisfaction with the new protocol because this information had not been collected for all esophagectomy patients at their time of discharge and follow-up visits. Patients' satisfaction is an important indicator of quality of care to help evaluate efficacy of a new protocol. For FTEP, patient satisfaction may be driven by various factors including pain management, ability to swallow, early ambulation, fewer postoperative complications, and enhanced recovery. However, we had collected data on difficulty in swallowing noted during the patient's postoperative follow-up visits and found it to be similar across both group A (11%) and group B (9%, P = 0.151). In the future, survey studies should be conducted to assess patients' satisfaction and approval of the fast-track protocol. Another potential limitation of our study is that in the cost-effectiveness analysis, we performed only univariable and multivariable analyses to compare the overall technical charges in group A with those in group B. A detailed analysis of the cost-effectiveness of an FTEP using a more systematic approach is beyond the scope of this article and will be published separately. More prospective randomized studies are needed to support the use of a fast-track protocol for esophageal cancer patients and provide evidence of the protocol's cost-effectiveness.
Discussion
In our study, we demonstrated that a fast-track setup significantly reduced LOS and technical hospital charges as well as the incidence of pulmonary complications without affecting rates of hospital readmission and 30- and 90-day mortality. Taken together, our findings show that the institution of the FTEP was safe and reduced hospital charges.
In the face of escalating health care costs, reducing patients' length of postoperative stay and number of postoperative complications is key to using medical resources optimally. Despite major advancements in the perioperative management of esophageal cancer patients, esophagectomy remains significantly associated with high incidences of mortality and morbidity. Over the last decade, fast-track protocols have been used successfully for several surgical specialties as well as for esophagectomy. In 1998, Brodner et al conducted a retrospective cohort study that showed that a multimodal approach can be used to enhance recovery after esophagectomy. In 2003, Chandrashekar et al, who suggested that patients could be safely transferred to and managed on a high-dependency unit following immediate extubation after 2-stage esophagectomy, were the first to mention an FTEP. In 2004, Cerfolio et al were the first to publish a study of a fast-track protocol for esophagectomy. Later retrospective cohort studies showed that FTEP was associated with reduced LOS. A recent single-institution, randomized clinical trial also showed that an enhanced recovery protocol for esophagectomy resulted in a small but significant reduction in LOS.
Detailed descriptions of the clinical care pathways of the traditional esophagectomy protocol and the FTEP used at our institution are given in Table 3. As part of the FTEP, patients were immediately extubated after surgery, transferred to the postanesthesia care unit only for a few hours, and then transferred to the telemetry unit. However, 7% of patients on FTEP still went to ICU because these were high-risk salvage esophageal resection patients who had other comorbidities that required ventilator support immediately after surgery. In the telemetry unit, the patients' vital signs, chest tube output, and urine output were monitored hourly, and the patients were allowed to ambulate within 4 hours of their arrival to the floor. Early ambulation reduces postoperative stress and fatigue and facilitates recovery. The reduced LOS could be attributed to close monitoring and keeping patients ambulatory in the telemetry unit.
Perioperative fluid therapy plays an important role in the care of patients after esophagectomy. Patients on an FTEP are typically recommended to receive a balanced rather than restrictive regimen of preoperative fluid therapy as well as epidural analgesia for postoperative pain management. In our study, there was not much difference in perioperative fluid therapy and postoperative pain management between patients on the traditional esophagectomy protocol and those on the FTEP. For perioperative fluid therapy, patients on the traditional esophagectomy protocol as well as those on the FTEP received 5% dextrose in half the amount of normal saline (0.45% w/v of sodium chloride) at a rate of 125 mL/h on the day of surgery and postoperative day (POD) 1 and POD 2. After POD 2, the volume of fluid administered was reduced gradually, from 125 mL/h on POD 3 to 75 mL/h on POD 4, 50 mL/h on POD 5, 21 mL/h on POD 6, and finally to saline lock on POD 7. For their postoperative pain, patients received epidural analgesia with 5 μg/mL hydromorphone administered with 0.075% bupivacaine at a rate of 10 mL/h continuously, with patient boluses of 3 mL administered every 10 minutes and clinician boluses of 5 mL administered every 3 hours as needed. This pain management regimen was continued for a maximum of 7 days or stopped early if the patient's chest tubes were removed before that time. The proportion of patients who were discharged on J-tube feeding without barium swallow in the FTEP group (65%) was significantly larger than that in the traditional protocol group (31%; P < 0.001). For patients on the FTEP, a barium swallow was performed between 10 and 15 days after discharge on an outpatient basis and the J-tube was removed 4 to 6 weeks after discharge, whenever the patient could take in most of the calories by mouth. Although J-tube feeding has been found to be a safe and effective method of providing postoperative nutritional support, it has not been part of the FTEPs other studies have investigated. Thus, additional studies to investigate the use of J-tube feeding in this setting are warranted. Also, no additional outpatient care was required for fast-track patients over the standard pathway. We had a standard follow-up for all esophagectomy patients. First follow-up was done at 6 weeks after discharge, next 3 follow-ups were done every 6 months, and later a yearly follow-up was done.
Patients' baseline characteristics such as age and comorbidities including diabetes, COPD, and coronary artery disease are significant predictors of morbidity and mortality after esophagectomy. In our study, groups A and B had similar proportions of patients with these predictors. In terms of perioperative treatment, the proportion of patients who received neoadjuvant chemoradiotherapy in group B (85%) was higher than that in group A (73%). One meta-analysis showed that, compared with surgery alone, neoadjuvant chemoradiotherapy plus surgery is associated with a higher risk of mortality. With regard to tumor characteristics, the patients in group B had larger, more clinically advanced tumors than the patients in group A did. Although these characteristics put patients in group B at a higher risk of poor outcomes, these patients had better outcomes than the patients in group A did even after adjustment for these predictors in the multivariable analysis.
One recent trend in localized esophageal carcinoma surgery is MIE, which utilizes a combined thoracoscopic and laparoscopic approach or a hybrid approach. Systematic reviews comparing MIE with conventional methods of open surgery (ie, transthoracic and transhiatal esophagectomy) found MIE to be safe and associated with better postoperative outcomes. In this study, MIE was not part of the FTEP. Given that MIE is a recent development, the proportion of patients who underwent MIE in group B was unsurprisingly higher than that in group A. Multivariable analysis revealed MIE to be associated with pulmonary complications but not LOS.
The anastomotic leak rate (14% in group A vs 13% in group B, P = 0.581) seems high because leaks were calculated including clinically nonsignificant leaks, which required no intervention (Table 5). Anastomotic leak was classified as grade 1, small contained leak in barium or CT requiring no intervention or basic treatment, such as giving antibiotic, or observation; grade 2, small contained leak requiring minimum intervention, such as stent or drainage placement; grade 3, leak requiring a repeat operation; and grade 4, conduit loss requiring conduit resection (Table 5). For patients who had an anastomotic leak, the mean LOS increased by 2 days but there was no difference in 30 days perioperative mortality (2.1% in leak group vs 2.9% in no leak group, P = 1.000).
Our study, which included patients treated on a traditional esophagectomy protocol during a 4-year period immediately before the institution of an FTEP as well as patients treated on an FTEP during its first 4 years of implementation, enabled us to thoroughly assess postoperative outcomes in a large group of patients over a long period. Owing to the introduction of an FTEP in March 2008, we reduced the proportion of patients who were immediately transferred to the SICU after esophagectomy from 71% in March 2004 to just 7% in March 2012 (Table 5). Ours is one of the first studies conducted in the United States to assess the impact of an FTEP on hospital charges. In our study, there was about 17% reduction in the median technical charges and 31% reduction in the mean technical charges after institution of an FTEP. The reduction in hospital charges can be contributed to decreased SICU days, LOS, and postoperative complication rate in group B patients. This suggested that an FTEP reduced hospital charges without compromising the safety of the patients.
Our study had a few potential limitations. Although we assessed important outcomes such as patient safety and LOS, we did not assess patients' satisfaction with the new protocol because this information had not been collected for all esophagectomy patients at their time of discharge and follow-up visits. Patients' satisfaction is an important indicator of quality of care to help evaluate efficacy of a new protocol. For FTEP, patient satisfaction may be driven by various factors including pain management, ability to swallow, early ambulation, fewer postoperative complications, and enhanced recovery. However, we had collected data on difficulty in swallowing noted during the patient's postoperative follow-up visits and found it to be similar across both group A (11%) and group B (9%, P = 0.151). In the future, survey studies should be conducted to assess patients' satisfaction and approval of the fast-track protocol. Another potential limitation of our study is that in the cost-effectiveness analysis, we performed only univariable and multivariable analyses to compare the overall technical charges in group A with those in group B. A detailed analysis of the cost-effectiveness of an FTEP using a more systematic approach is beyond the scope of this article and will be published separately. More prospective randomized studies are needed to support the use of a fast-track protocol for esophageal cancer patients and provide evidence of the protocol's cost-effectiveness.