Acta Oto-Laryngologica. 2014; 134: 760–767
ORIGINAL ARTICLE
Percutaneous endoscopic gastrostomy tube placement by otorhinolaryngologist-head and neck surgeons
LEIF J. J. BÄCK1, ALEXANDER BENDERS1, PETRA PIETARINEN1, HARRI KESKI-SÄNTTI1, MARI MARKKANEN-LEPPÄNEN1, MARIANNE UDD2, JORMA HALTTUNEN2, ANTTI A. MÄKITIE1* & LEENA KYLÄNPÄÄ2* Departments of Otorhinolaryngology – Head and Neck Surgery and 2Surgery, Helsinki University Central Hospital and University of Helsinki, Faculty of Medicine, Institute of Clinical Medicine, Helsinki, Finland
1
Abstract Conclusion: Percutaneous endoscopic gastrostomy (PEG) tube placement by an otorhinolaryngologist-head and neck surgeon is a feasible procedure with logistical advantages for the patient. Patient selection, co-morbidities, and the prognosis of the underlying disease are factors determining the outcome. Patient evaluation by a multidisciplinary team, with a gastroenterologist surgeon as a technical adviser, is proposed. Objective: PEG tube placement offers an alternative to enteral nutrition. We aimed to analyze complication rates after PEG tube placement in order to evaluate the changed management policy. Methods: This was a retrospective review of complication rates in two patient cohorts with consecutive PEG tube placement at the Departments of Otorhinolaryngology – Head and Neck Surgery (group I, n = 120) and Surgery (group II, n = 172) at Helsinki University Central Hospital, Helsinki, Finland. Data were collected on the patients’ age, sex, preoperative condition, tumor site and stage, preoperative laboratory parameters, coexisting medical diagnoses, indication and date for PEG tube placement, complications, time of PEG use, follow-up time, and clinical status at the last follow-up. Results: The only baseline differences between the cohorts were a higher ASA classification and fewer prophylactic PEG tubes in group II. The rate of major complications was 7.5% in group I and 13.9% in group II; in group I the rate of minor complications was 25%, compared with 15% in group II; and the procedure-related mortality rate was 0.8% in group I and 0.5% in group II. The differences were not significant (p = 0.105–0.795).
Keywords: Head and neck cancer, prophylactic, therapeutic, complication, mortality
Introduction Percutaneous endoscopic gastrostomy (PEG) tube placement was first described in 1980 by Gauderer et al. [1]. PEG tubes allow efficient maintenance of optimal nutrition in patients with long-lasting dysphagia for various reasons. It has now been established as the method of choice for long-term enteral nutrition due to its rapid insertion and good patient tolerance. The American Gastroenterological Association recommends PEG tube placement in cases when
tube feeding is expected to exceed 30 days. Controversy exists regarding the optimal timing of this procedure. Serious and even lethal complications may occur and awareness of the spectrum of these events and their early clinical manifestations is vital [2]. However, PEG tube placement has not been shown to improve survival and is associated with considerable health-care costs [3]. PEG tube placement, never an emergency procedure, ought to improve quality of life rather than only prolong the terminal phase of a malignant disease. Therefore, the number of unnecessary procedures should be
Correspondence: Dr Leif J. J. Bäck, Department of Otorhinolaryngology – Head & Neck Surgery, Helsinki University Central Hospital, PO Box 220, FIN – 00029, HUCH, Helsinki, Finland. Tel: +358 50 3382281/+358 50 4271490/+358 9 4711. E-mail: leif.back@helsinki.fi This paper was presented at the 5th European Head and Neck Society Meeting in Poznan, Poland, April 18-21, 2012. *These authors contributed equally to this project.
(Received 10 January 2014; accepted 7 February 2014) ISSN 0001-6489 print/ISSN 1651-2251 online 2014 Informa Healthcare DOI: 10.3109/00016489.2014.895040
PEG by otolaryngologists-head and neck surgeons minimized and regular assessment of outcomes is warranted. PEG tube placement has traditionally been performed in gastrointestinal departments. However, some advocate an advantage for patients to have their PEG tube placed by an otorhinolaryngologist-head and neck surgeon in combination with their other procedures in head and neck cancer management, such as panendoscopy, tracheostomy, tumor biopsy, and definitive surgical treatment [2,4]. Therefore, this policy would obviously result in a logistical benefit, i.e. it would shorten the treatment delay. Since 2008, PEG tubes have also been placed at the Department of Otorhinolaryngology – Head and Neck Surgery at our institution. To evaluate the change in policy, we analyzed the types and rates of complications of PEG tube placements performed at the Department of Otorhinolaryngology – Head and Neck Surgery. The results were compared with corresponding figures for a group of patients who had received their PEG tube at the Department of Surgery. Material and methods We retrospectively reviewed and compared data from two cohorts of patients: study group I, that had undergone PEG tube placement from October 2008 until October 2010 at the Department of Otorhinolaryngology – Head and Neck Surgery, Helsinki University Central Hospital (HUCH), Helsinki, Finland, and study group II, who had their PEG tubes placed at the Department of Surgery from September 2005 until December 2009 (referred from the Department of Otorhinolaryngology – Head and Neck Surgery). The health-care district of HUCH includes approximately 1.8 million inhabitants. Hospital surgical and discharge registries were used to identify the patients. Medical records were studied and details were collected on the patients’ age, sex, preoperative condition (American Society of Anesthesiologists Physical Status Classification, ASA), tumor site and stage, preoperative laboratory parameters, coexisting medical diagnoses (Charlson Comorbidity Index, CCI) [5], indication and date for PEG tube placement, complications, time of PEG use, followup time, and clinical status at the last follow-up. The study period was chosen to run from PEG tube placement to the last clinical evaluation (minimum 12 months) or the time of death. Complications were divided into early (£30 days) and late complications (>30 days), and additionally, into major and minor complications [6]. PEG tube placement during a specific time period with no additional interventions is regarded as normal
761
clinical practice. Therefore, no formal Research Ethics Board approval was necessary for the evaluation of the outcome of these procedures. However, an institutional research permission was granted for the study protocol (§140, September 28, 2010). To ensure a successful change of policy regarding PEG tube placements at our institution, a training period at the Department of Surgery was set up for the otorhinolaryngologist-head and neck surgeons, followed by the presence of a gastrointestinal surgeon during the first procedures in the Department of Otorhinolaryngology – Head and Neck Surgery. The PEG tube placement procedures were all performed by a team of two otorhinolaryngologist-head and neck surgeons. The patients were sedated and local anesthesia (10 mg/ml lidocaine; Lidocard, Orion, Espoo, Finland) was used on the abdominal wall; the procedure was performed using the percutaneous approach with pull-through technique [2]. After pulling the PEG tube in place, a control endoscopy was performed to confirm the accurate position of the PEG bumper. Only PEG tubes of 20 French (MIC percutaneous endoscopic gastrostomy kit, Kimberly-Clark NV, Zaventum, Belgium) were used. After 3–5 days, the fixing plate was loosened to avoid the silicone cap becoming buried in the gastric mucosa. The patients were advised to keep the skin in the area clean and to rotate the PEG tube daily to prevent skin problems. All patients, except those with ongoing antibiotic therapy, received a single dose of antibiotics (cefuroxime; Zinacef, GlaxoSmithKline, Espoo, Finland) before PEG tube placement. A specialized head and neck nurse gave the preoperative information, loosened the fixing plate postoperatively, and advised the patients on further contact if necessary. The contraindications for PEG tube placement were an acute electrolyte imbalance, active coagulopathy, morbid obesity (BMI ‡40 kg/m2), large volume ascites, a previous gastrectomy, and sepsis. The original PEG tube was replaced within 12 months and thereafter every third month (gastrostomy feeding tube and MIC-KEY low profile gastrostomy feeding tube, Kimberly-Clark NV). The PEG tube was removed as soon as the patient was able to maintain body weight by oral nutrition. We report values as means with standard deviations (SDs) and range for descriptive purposes. Percentages are rounded to the nearest whole number and therefore do not always add up to 100%. The equality of the study groups and the comparison of their complication and mortality rates were evaluated using the Mann–Whitney U test for continuous variables and the Kruskal–Wallis test for categorical data. The results were generated using a computerized statistical package (IBM SPSS Statistics 19.0, Armonk, NY,
762
L. J. J. Bäck et al.
USA). All p values are two-sided and the significance level is set at 0.05 throughout. This trial was registered at clinicaltrials.gov. NCT 01476241. Results Preclinical data and the complication and mortality rates in both study groups are presented in Table I. A team of two otorhinolaryngologist-head and neck surgeons performed all the PEG tube placements in study group I, consisting of 120 consecutive patients. Eighty-eight (73.3%) were males and 32 (26.7%) were females, with a mean age of 61.5 years (SD ± 9.6, range 27–92 years). The only difference between the study groups in the preclinical data was seen in the ASA classification and the amount of prophylactic PEG tube placements (Table I). No patients were lost during follow-up. Procedures and outcome in study group I In 114 head and neck cancer patients (95.0%), the indication for PEG tube placement was primary (95 patients) or adjuvant (19 patients) chemoradiation therapy. The remaining six patients suffered from dysphagia due to pharyngeal stenosis caused by earlier Table I. Preclinical data and complication and mortality rates in both study groups (mean and range). Characteristic
Study group I (n = 120)
Age (years)
61 (27–92)
Men (%)
88 (73.3)
Study group II (n = 172) 62 (26–90) 125 (72.3)
BMI (kg/m2)
23.9 (13.3–37.2) 23.3 (13.5–39.8)
ASA
2.11 (1–4)
2.63 (1–4)
p value 0.876 0.839 0.368 < 0.001
CCI
0.87 (0–8)
0.94 (0–6)
0.617
CCIaa
1.86 (0–11)
1.81 (0–8)
0.856
HNC (%)
117 (97.5)
165 (95.9)
pPEG (%)
114 (95.0)
134 (77.9)
Minor
30 (25.0)
26 (15.1)
0.105
Major
9 (7.5)
24 (13.9)
0.065
Procedure-related
1 (0.8)
1 (0.5)
0.795
ORIGINAL ARTICLE
Percutaneous endoscopic gastrostomy tube placement by otorhinolaryngologist-head and neck surgeons
LEIF J. J. BÄCK1, ALEXANDER BENDERS1, PETRA PIETARINEN1, HARRI KESKI-SÄNTTI1, MARI MARKKANEN-LEPPÄNEN1, MARIANNE UDD2, JORMA HALTTUNEN2, ANTTI A. MÄKITIE1* & LEENA KYLÄNPÄÄ2* Departments of Otorhinolaryngology – Head and Neck Surgery and 2Surgery, Helsinki University Central Hospital and University of Helsinki, Faculty of Medicine, Institute of Clinical Medicine, Helsinki, Finland
1
Abstract Conclusion: Percutaneous endoscopic gastrostomy (PEG) tube placement by an otorhinolaryngologist-head and neck surgeon is a feasible procedure with logistical advantages for the patient. Patient selection, co-morbidities, and the prognosis of the underlying disease are factors determining the outcome. Patient evaluation by a multidisciplinary team, with a gastroenterologist surgeon as a technical adviser, is proposed. Objective: PEG tube placement offers an alternative to enteral nutrition. We aimed to analyze complication rates after PEG tube placement in order to evaluate the changed management policy. Methods: This was a retrospective review of complication rates in two patient cohorts with consecutive PEG tube placement at the Departments of Otorhinolaryngology – Head and Neck Surgery (group I, n = 120) and Surgery (group II, n = 172) at Helsinki University Central Hospital, Helsinki, Finland. Data were collected on the patients’ age, sex, preoperative condition, tumor site and stage, preoperative laboratory parameters, coexisting medical diagnoses, indication and date for PEG tube placement, complications, time of PEG use, follow-up time, and clinical status at the last follow-up. Results: The only baseline differences between the cohorts were a higher ASA classification and fewer prophylactic PEG tubes in group II. The rate of major complications was 7.5% in group I and 13.9% in group II; in group I the rate of minor complications was 25%, compared with 15% in group II; and the procedure-related mortality rate was 0.8% in group I and 0.5% in group II. The differences were not significant (p = 0.105–0.795).
Keywords: Head and neck cancer, prophylactic, therapeutic, complication, mortality
Introduction Percutaneous endoscopic gastrostomy (PEG) tube placement was first described in 1980 by Gauderer et al. [1]. PEG tubes allow efficient maintenance of optimal nutrition in patients with long-lasting dysphagia for various reasons. It has now been established as the method of choice for long-term enteral nutrition due to its rapid insertion and good patient tolerance. The American Gastroenterological Association recommends PEG tube placement in cases when
tube feeding is expected to exceed 30 days. Controversy exists regarding the optimal timing of this procedure. Serious and even lethal complications may occur and awareness of the spectrum of these events and their early clinical manifestations is vital [2]. However, PEG tube placement has not been shown to improve survival and is associated with considerable health-care costs [3]. PEG tube placement, never an emergency procedure, ought to improve quality of life rather than only prolong the terminal phase of a malignant disease. Therefore, the number of unnecessary procedures should be
Correspondence: Dr Leif J. J. Bäck, Department of Otorhinolaryngology – Head & Neck Surgery, Helsinki University Central Hospital, PO Box 220, FIN – 00029, HUCH, Helsinki, Finland. Tel: +358 50 3382281/+358 50 4271490/+358 9 4711. E-mail: leif.back@helsinki.fi This paper was presented at the 5th European Head and Neck Society Meeting in Poznan, Poland, April 18-21, 2012. *These authors contributed equally to this project.
(Received 10 January 2014; accepted 7 February 2014) ISSN 0001-6489 print/ISSN 1651-2251 online 2014 Informa Healthcare DOI: 10.3109/00016489.2014.895040
PEG by otolaryngologists-head and neck surgeons minimized and regular assessment of outcomes is warranted. PEG tube placement has traditionally been performed in gastrointestinal departments. However, some advocate an advantage for patients to have their PEG tube placed by an otorhinolaryngologist-head and neck surgeon in combination with their other procedures in head and neck cancer management, such as panendoscopy, tracheostomy, tumor biopsy, and definitive surgical treatment [2,4]. Therefore, this policy would obviously result in a logistical benefit, i.e. it would shorten the treatment delay. Since 2008, PEG tubes have also been placed at the Department of Otorhinolaryngology – Head and Neck Surgery at our institution. To evaluate the change in policy, we analyzed the types and rates of complications of PEG tube placements performed at the Department of Otorhinolaryngology – Head and Neck Surgery. The results were compared with corresponding figures for a group of patients who had received their PEG tube at the Department of Surgery. Material and methods We retrospectively reviewed and compared data from two cohorts of patients: study group I, that had undergone PEG tube placement from October 2008 until October 2010 at the Department of Otorhinolaryngology – Head and Neck Surgery, Helsinki University Central Hospital (HUCH), Helsinki, Finland, and study group II, who had their PEG tubes placed at the Department of Surgery from September 2005 until December 2009 (referred from the Department of Otorhinolaryngology – Head and Neck Surgery). The health-care district of HUCH includes approximately 1.8 million inhabitants. Hospital surgical and discharge registries were used to identify the patients. Medical records were studied and details were collected on the patients’ age, sex, preoperative condition (American Society of Anesthesiologists Physical Status Classification, ASA), tumor site and stage, preoperative laboratory parameters, coexisting medical diagnoses (Charlson Comorbidity Index, CCI) [5], indication and date for PEG tube placement, complications, time of PEG use, followup time, and clinical status at the last follow-up. The study period was chosen to run from PEG tube placement to the last clinical evaluation (minimum 12 months) or the time of death. Complications were divided into early (£30 days) and late complications (>30 days), and additionally, into major and minor complications [6]. PEG tube placement during a specific time period with no additional interventions is regarded as normal
761
clinical practice. Therefore, no formal Research Ethics Board approval was necessary for the evaluation of the outcome of these procedures. However, an institutional research permission was granted for the study protocol (§140, September 28, 2010). To ensure a successful change of policy regarding PEG tube placements at our institution, a training period at the Department of Surgery was set up for the otorhinolaryngologist-head and neck surgeons, followed by the presence of a gastrointestinal surgeon during the first procedures in the Department of Otorhinolaryngology – Head and Neck Surgery. The PEG tube placement procedures were all performed by a team of two otorhinolaryngologist-head and neck surgeons. The patients were sedated and local anesthesia (10 mg/ml lidocaine; Lidocard, Orion, Espoo, Finland) was used on the abdominal wall; the procedure was performed using the percutaneous approach with pull-through technique [2]. After pulling the PEG tube in place, a control endoscopy was performed to confirm the accurate position of the PEG bumper. Only PEG tubes of 20 French (MIC percutaneous endoscopic gastrostomy kit, Kimberly-Clark NV, Zaventum, Belgium) were used. After 3–5 days, the fixing plate was loosened to avoid the silicone cap becoming buried in the gastric mucosa. The patients were advised to keep the skin in the area clean and to rotate the PEG tube daily to prevent skin problems. All patients, except those with ongoing antibiotic therapy, received a single dose of antibiotics (cefuroxime; Zinacef, GlaxoSmithKline, Espoo, Finland) before PEG tube placement. A specialized head and neck nurse gave the preoperative information, loosened the fixing plate postoperatively, and advised the patients on further contact if necessary. The contraindications for PEG tube placement were an acute electrolyte imbalance, active coagulopathy, morbid obesity (BMI ‡40 kg/m2), large volume ascites, a previous gastrectomy, and sepsis. The original PEG tube was replaced within 12 months and thereafter every third month (gastrostomy feeding tube and MIC-KEY low profile gastrostomy feeding tube, Kimberly-Clark NV). The PEG tube was removed as soon as the patient was able to maintain body weight by oral nutrition. We report values as means with standard deviations (SDs) and range for descriptive purposes. Percentages are rounded to the nearest whole number and therefore do not always add up to 100%. The equality of the study groups and the comparison of their complication and mortality rates were evaluated using the Mann–Whitney U test for continuous variables and the Kruskal–Wallis test for categorical data. The results were generated using a computerized statistical package (IBM SPSS Statistics 19.0, Armonk, NY,
762
L. J. J. Bäck et al.
USA). All p values are two-sided and the significance level is set at 0.05 throughout. This trial was registered at clinicaltrials.gov. NCT 01476241. Results Preclinical data and the complication and mortality rates in both study groups are presented in Table I. A team of two otorhinolaryngologist-head and neck surgeons performed all the PEG tube placements in study group I, consisting of 120 consecutive patients. Eighty-eight (73.3%) were males and 32 (26.7%) were females, with a mean age of 61.5 years (SD ± 9.6, range 27–92 years). The only difference between the study groups in the preclinical data was seen in the ASA classification and the amount of prophylactic PEG tube placements (Table I). No patients were lost during follow-up. Procedures and outcome in study group I In 114 head and neck cancer patients (95.0%), the indication for PEG tube placement was primary (95 patients) or adjuvant (19 patients) chemoradiation therapy. The remaining six patients suffered from dysphagia due to pharyngeal stenosis caused by earlier Table I. Preclinical data and complication and mortality rates in both study groups (mean and range). Characteristic
Study group I (n = 120)
Age (years)
61 (27–92)
Men (%)
88 (73.3)
Study group II (n = 172) 62 (26–90) 125 (72.3)
BMI (kg/m2)
23.9 (13.3–37.2) 23.3 (13.5–39.8)
ASA
2.11 (1–4)
2.63 (1–4)
p value 0.876 0.839 0.368 < 0.001
CCI
0.87 (0–8)
0.94 (0–6)
0.617
CCIaa
1.86 (0–11)
1.81 (0–8)
0.856
HNC (%)
117 (97.5)
165 (95.9)
pPEG (%)
114 (95.0)
134 (77.9)
Minor
30 (25.0)
26 (15.1)
0.105
Major
9 (7.5)
24 (13.9)
0.065
Procedure-related
1 (0.8)
1 (0.5)
0.795
