[Considerations for the Performance and Quality Assurance of Outpatient Surgery in Otorhinolaryngology, Head and Neck Surgery in Germany]. / Erwägungen zur Durchführung und Qualitätssicherung ambulanter Operationen im HNO-Bereich in Deutschland.

BACKGROUND: German health policy has propagated an expansion of outpatient surgeries and procedures and initiated the discussion about this. Otorhinolaryngology, head and neck surgery offers opportunities to provide currently inpatient procedures on an outpatient basis. METHODS: The German Society of Otorhinolaryngology, Head and Neck Surgery, and the German Professional Association of Otorhinolaryngologists established working groups to assess and evaluate the ENT-specific aspects of shifting services to the outpatient setting. The working groups were given the task of developing and considering organizational, structural and personnel definitions of quality assurance. RECOMMENDATION: Facts were determined in detail, which exclude an ambulatory operation in the ENT-specialty. This was based on both surgery-related and patient-related facts. Finally, operations were named which can be performed as outpatient operations. DISCUSSION: An evaluation was performed from the ENT specialist's perspective. A prerequisite for outpatient treatment is a reorganization of remuneration. The current DRG and EBM system do not provide a satisfactory framework for this, and the EBM does not allow for the economic provision of surgical interventions in otorhinolaryngology, head and neck surgery. The development of an appropriate financing model is as imperative for a successful implementation as the integration and financing of further training of ENT physicians.

[Good local control by supracricoid partial laryngectomy (SCPL)]. / Gute lokale Kontrolle durch supracricoide partielle Laryngektomie.

The suprachoroidale partial laryngectomy (SCPL) can provide organ-preserving alternative to total laryngectomy in selected endolaryngeal malignancies. In a large case series Sperry et al. retrospectively analyzed the surgical and oncological outcome.

Polydimethylsiloxane for injection laryngoplasty: two cases necessitating tracheotomy.

The surgical treatment of glottic insufficiency due to lesions of the recurrent laryngeal nerve has become a routine procedure in the last few decades. In particular, injection laryngoplasty with polydimethylsiloxane (PDMS) has proved to be an easy, effective and safe method for vocal fold medialization. It is a biologically inert substance having almost ideal properties as a filler; complications related to its intralaryngeal use such as migration, or granuloma formation are extremely rare and allergic reactions have not been reported as yet. We discuss two cases representing the first description of acute severe complications after injection laryngoplasty with PDMS.

EORTC trial 11001: distribution of two 10B-compounds in patients with squamous cell carcinoma of head and neck, a translational research/phase 1 trial.

Boron neutron capture therapy (BNCT) provides highly targeted delivery of radiation through the limited spatial distribution of its effects. This translational research/phase I clinical trial investigates whether BNCT might be developed as a treatment option for squamous cell carcinoma of head and neck (SCCHN) relying upon preferential uptake of the two compounds, sodium mercaptoundecahydro-closo-dodecaborate (BSH) or L-para-boronophenylalanine (BPA) in the tumour. Before planned tumour resection, three patients received BSH and three patients received BPA. The (10)B-concentration in tissues and blood was measured with prompt gamma ray spectroscopy. Adverse effects from compounds did not occur. After BPA infusion the (10)B-concentration ratio of tumour/blood was 4.0 +/- 1.7. (10)B-concentration ratios of tumour/normal tissue were 1.3 +/- 0.5 for skin, 2.1 +/- 1.2 for muscle and 1.4 +/- 0.01 for mucosa. After BSH infusion the (10)B-concentration ratio of tumour/blood was 1.2 +/- 0.4. (10)B-concentration ratios of tumour/normal tissue were 3.6 +/- 0.6 for muscle, 2.5 +/- 1.0 for lymph nodes, 1.4 +/- 0.5 for skin and 1.0 +/- 0.3 for mucosa. BPA and BSH deliver (10)B to SCCHN to an extent that might allow effective BNCT treatment. Mucosa and skin are the most relevant organs at risk.

Value of postoperative radiotherapy in patients with pathologic N1 neck disease.

BACKGROUND: The aim of this study was to assess the efficacy of postoperative radiotherapy for the treatment of patients with pathologic N1 neck disease. METHODS: One hundred eighteen consecutive patients with upper aerodigestive tract cancer who were initially treated with curative surgery between 1986 and 2002 and had pN1 disease without extracapsular spread were reviewed. Postoperative radiotherapy was given to 46 patients. RESULTS: Eight isolated regional recurrences were observed, 3 of which occurred in contralateral undissected necks. Seven of the 72 patients treated with surgery alone and 1 of the 46 who received postoperative radiotherapy were affected. The respective 3-year neck recurrence rates amounted to 11.2% and 2.9% (p = .0921). A survival benefit of irradiated patients could not be established. CONCLUSIONS: The data confirm a trend toward improved regional control of pN1 disease if postoperative radiotherapy is applied. However, as a survival benefit is uncertain, use of radiation treatment cannot be recommended generally, but requires individual decisions.

Organ preserving transoral laser microsurgery for cancer of the hypopharynx.

OBJECTIVE: To assess the feasibility of transoral laser microsurgery (TLM) in the treatment of hypopharyngeal cancer, with a special focus on piriform sinus carcinomas, and to report the oncologic and functional outcomes. STUDY DESIGN: Prospective case-series study at a single institute, an academic tertiary referral center. METHODS: A total of 172 patients with previously untreated squamous cell carcinoma of the hypopharynx were eligible for this study (1986-2003). The piriform sinus was the most common localization (n = 150). Patients with simultaneous second primaries, distant metastases, or N3 neck disease and cancers of the category pT4b were excluded. Fifteen percent of the patients had stages I and II (according to guidelines from the Union Internationale Contre le Cancer 2002/American Joint Commission on Cancer, 2002), and 85% had stages III and IVa. The median follow-up period was 45 months. All patients (n = 172) were treated by TLM, mainly by selective neck dissection (93%) and/or postoperative radiotherapy (52%). Overall survival, recurrence-free survival, organ preservation, and local control were analyzed as end points. Rate of tracheotomies, postoperative complications, and swallowing function (feeding tube dependency) were also analyzed. RESULTS: : Five-year Kaplan-Meier local control was 84% for pT1; 70% for pT2; 75% for pT3; and 57% for pT4a. Five-year Kaplan-Meier recurrence-free survival was 73% for stages I and II, 59% for stage III, and 47% for stage IVa. The whole group of 172 hypopharyngeal cancer patients was analyzed, with an additional special focus on the homogenous group of piriform sinus carcinomas (n = 150). CONCLUSIONS: Our data support the conclusion that TLM is a valid option to standard radical surgery or standard conservation treatment. Oncologic and functional results compare favorably, while morbidity and complication rates tend to be lower.

Twenty-five years experience with laser surgery for head and neck tumors : report of an international symposium, Göttingen, Germany, 2005.

During the last 25 years, the treatment of tumors arising in the upper aerodigestive tract has changed fundamentally. Whereas surgery in the 1970s aimed at radical block resection and defect repair from outside, the establishment of transoral laser microsurgery marked a new era of organ- and function-preserving therapy. An international symposium, held on 10 and 11 June 2005 in Göttingen, was dedicated to a critical review and assessment of the current role of laser surgery for the treatment of head and neck cancer. Experts from five continents presented their experiences and scientific results and had an intensive exchange with participants from different countries. The topics of the symposium were focused on the surgical principles of laser resection, the oncological and functional results in comparison with traditional therapy, the difficulties and limits of laser surgery in distinct anatomical regions and on the role of radiotherapy. This report summarizes the most important results and statements and gives an overview of actual developments. The names and addresses of the participants mentioned in this report are appended below.

Efficacy of radiologic screening for distant metastases and second primaries in newly diagnosed patients with head and neck cancer.

OBJECTIVES: Detection of distant metastases and second primary tumors in newly diagnosed patients with head and neck cancer has usually a major effect on prognosis but does not always influence clinical management. This must be considered when radiologic screening investigations are used. The present study particularly evaluates how often additional neoplastic lesions detected by screening had an impact on therapy. STUDY DESIGN: The authors conducted a single-institution retrospective analysis. METHODS: The medical records of 260 patients with newly diagnosed squamous cell carcinoma of the head and neck treated between 1999 and 2002 were retrospectively analyzed. Before therapy, all patients had undergone screening by computed tomography scan of the chest, abdominal ultrasound, and bone scintigraphy. RESULTS: Screening investigations identified 16 patients (6.2%) with distant metastases and six patients (2.3%) with simultaneous second primaries. Chest computed tomography scan detected 20 neoplastic lesions; abdominal ultrasound and bone scintigraphy each detected 2. Three findings of distant metastases proved to be false-positive during follow up. Of the 22 patients with positive screening results, clinical management was affected in 13 (59.1%). Twelve were originally scheduled for curative surgery and 10 had chest abnormalities. CONCLUSION: Chest computed tomography scan was the most effective screening investigation, which should be routinely used whenever curative surgery of head and neck cancer is planned. Abdominal ultrasound and bone scintigraphy may sometimes be valuable before extensive surgical treatment of far advanced disease. In patients scheduled for primary radiotherapy, radiologic screening had hardly any consequence and should be confined to conventional x-ray of the chest.

Impact of re-resection for inadequate margins on the prognosis of upper aerodigestive tract cancer treated by laser microsurgery.

OBJECTIVES: Positive or uncertain surgical margins left untreated have a distinct prognostic relevance in squamous cell carcinoma of the upper aerodigestive tract. An advantage of transoral laser microsurgery is that it can be easily repeated if inadequate resection margins are found postoperatively. The present study investigates the impact of laser surgical reresection on the outcome of patients. STUDY DESIGN: The authors conducted a retrospective unicenter study. METHODS: A review of 1,467 patients with squamous cell carcinoma of the upper aerodigestive tract who were initially treated by transoral laser microsurgery with curative intent between August 1986 and December 2002 was conducted. Locoregional control as well as TNM adjusted and overall survival were analyzed using the Kaplan-Meier method. RESULTS: Three hundred eighty-six patients have required reresection to obtain clear surgical margins, in 70 of whom residual carcinoma has been detected in revision specimens. Patients without need for revision and those in whom revision specimens were found tumor-free had an almost identical locoregional control (P = .4611). In patients with positive revision specimens, however, locoregional control was significantly worsened (P = .0058). Neither the need for reresection nor the detection of further tumor tissue in revision specimens affected TNM adjusted or overall survival. CONCLUSIONS: Survival of patients was similar whether clear resection margins were reached within the first surgical step or with revision surgery. However, patients in whom reresection specimens contained residual carcinoma had an increased risk of locoregional failure and should undergo a further reresection or at least a very close follow up.

Adjuvant radiotherapy after transoral laser microsurgery for advanced squamous carcinoma of the head and neck.

PURPOSE: To evaluate the efficacy of an adjuvant radiotherapy after transoral laser microsurgery for advanced squamous cell carcinoma of the head and neck and to show that a less invasive surgery with organ preservation in combination with radiotherapy is an alternative to a radical treatment. PATIENTS AND METHODS: Between 1987 and 2000, 208 patients with advanced squamous cell carcinoma of the head and neck were treated with postoperative radiotherapy after surgical CO2 laser resection. Primary sites included oral cavity, 38; oropharynx, 88; larynx, 36; hypopharynx, 46. Disease stages were as follows: Stage III, 40 patients; Stage IV, 168 patients. Before 1994, the treatment consisted of a split-course radiotherapy with carboplatinum (Treatment A). After 1994, the patients received a conventional radiotherapy (Treatment B). RESULTS: Patients had 5-year locoregional control and disease-specific survival (DSS) rates of 68% and 48%, respectively. The 5-year DSS was 70% and 44% for Stages III and IV, respectively (p = 0.00127). Patients treated with a hemoglobin level greater or equal to 13.5 g/dL before radiotherapy had a 5-year DSS of 55% as compared with 39% for patients treated with a hemoglobin level greater than 13.5 g/dL (p = 0.0054). CONCLUSION: In this series of patients with advanced head-and-neck tumors, transoral laser surgery in combination with adjuvant radiotherapy resulted in locoregional control and DSS rates similar to those reported for radical surgery followed by radiotherapy. Treatment B has clearly been superior to Treatment A. A further improvement of our treatment regimen might be expected by the combination of adjuvant radiotherapy with concomitant platinum-based chemotherapy.