Ethical issues in non-intervention trials for thyroid cancer.

In recent years, the increasing numbers of small, apparently indolent thyroid cancers diagnosed in the world have encouraged investigators to consider non-intervention as an alternative to surgical management. In the following pages, the prospect of a non-intervention trial for thyroid cancer is considered with attention to the ethical issues that such a trial might raise. Such a non-intervention trial is analyzed relative to 7 ethical considerations: the social or scientific value of the research, the scientific validity of the trial, the necessity of fair selection of participants, a favorable risk-benefit ratio for trial participants, independent review of the trial, informed consent, and allowing the study participants to withdraw from the trial. A non-intervention trial for thyroid cancer is also considered relative to the central concept of equipoise.

Benign parotid hypertrophy on +HIV patients: limited late failures after external radiation.

PURPOSE: Although 8-10 Gy of external radiation therapy for +HIV associated parotid hypertrophy has achieved high response rates, the responses were transient with only 1/12 of patients retaining cosmetic control at median follow-up procedures of 9.5 months. Retreatment for failures after 8-10 Gy has also been unsatisfactory. Having shown that 24 Gy of external radiation therapy for benign parotid hypertrophy produced more durable cosmetic control than 8-10 Gy, we now report on longer follow-up periods on a group of patients receiving 24 Gy. MATERIALS AND METHODS: Twenty +HIV patients with clinical and radiographic evidence of lymphoepithelial lesions of the parotid were treated with 24 Gy of external radiation therapy using daily 1.5 Gy fractions; parallel opposed technique and 6 MV photons were used in 19 patients, and unilateral electron treatment was performed for one patient. RESULTS: With a mean follow-up period of 24 months, the cosmetic control appears durable. We have had no late failures past 24 months. Two patients have complained of modest xerostomia. There was no correlation with size of the cyst and eventual cosmetic result. CONCLUSIONS: Twenty-four Gy produces durable parotid control for HIV associated lymphoepithelial lesions of the parotid glands in +HIV patients. Failures after 2 years are uncommon and the side effects have been tolerable.

Close or positive margins after surgical resection for the head and neck cancer patient: the addition of brachytherapy improves local control.

PURPOSE: Microscopically positive or close margins after surgical resection results in an approximately 21-26% local failure rate despite excellent postoperative external radiation therapy. We sought to demonstrate improved local control in head and neck cancer patients who had a resection with curative intent, and had unexpected, microscopically positive or close surgical margins. METHODS AND MATERIALS: Twenty-nine patients with microscopically close or positive margins after curative surgery were given definitive, adjuvant external radiation therapy and 125I brachytherapy. All 29 patients had squamous cell cancer and tonsil was the most common subsite within the head and neck region. After external radiation therapy and thorough discussions with the attending surgeon and pathologists, the slides, gross specimens, and appropriate radiographs were reviewed and a target volume was determined. The target volume was the region of the margin in question and varied in size based on the surgery and pathologic results. Once the target volume was identified the patient was taken back to the operating room for insertion of 125I seeds. Activity implanted (range 2.9-21.5 millicuries) was designed to administer a cumulative lifetime dose of 120-160 Gy. RESULTS: Twenty-nine patients were followed for a median of 26 months (range 5-86 months). Two-year actuarial local control was 92%. CONCLUSION: 125I, after external radiation therapy, is an excellent method to improve local control in the subset of patients with unexpectedly unsatisfactory margins.

Surgical treatment of oral cavity carcinoma.

Ninety-four squamous cell carcinomas of the oral cavity, treated on the author's service between 1969 and 1981, were evaluated. The series included squamous cell carcinomas of various intraoral sites excluding the lips and hard palate. Survival of 60 mo was 70% for stage I, 65% for stage II, 45% for stage III, and 27% for stage IV carcinoma. Twenty-four of 34 patients with "early" cancer (stages I and II) were treated by operation alone. Too few patients with "early" cancer were treated by combined irradiation and surgery to draw conclusions regarding relative efficacy of combination therapy. Sixty patients had "advanced" cancer (stages III and IV). Five-year survival was 37% for patients treated by operation alone, 18% after salvage surgery after failed irradiation, and 60% for patients treated by operation combined with planned perioperative irradiation. Combination therapy appeared to improve control of locoregional disease as well as survival in patients with "advanced" cancer.

Reconstruction after pharyngolaryngectomy-esophagectomy.

Seventeen patients with carcinoma of the hypopharynx and/or cervical esophagus who require total pharyngolaryngectomy-esophagectomy are presented; Twenty-one different reconstructive methods were applied in the seventeen patients. An overall two year survival rate of 35 per cent was attained with effective palliation in 65 per cent of the patients. The Wookey and free jejunal transplantation procedures were unsuccessful as primary means of pharyngoesophageal reconstruction, although the Wookey principle was occasionally useful in salvaging failures of other procedures. The reversed deltopectoral flap was successfully employed in a small number of patients with only minimal extension below the cricopharyngeus but was found to be unfeasible in several other instances because of the extent of esophageal resection required. Transposition of the entire stomach was successfully employed in a number of suitable patients and is an excellent method of esophageal replacement in relatively healthy patients. The reversed gastric tube esophagoplasty was useful in more debilitated patients, with resection and reconstruction performed in separate stages.

Parathyroid re-exploration.

The authors evaluated their experience with 27 patients who required parathyroid re-explorations. The initial exploration was unsuccessful in 20 patients: in 8 because of ectopic lesions, in 2 because of undetected supernumerary glands, and in 10 because of inadequate exploration of the neck. All of the patients with inadequate neck explorations were found to have eutopic disease. Seven patients required re-exploration because of recurrent disease. Localization studies were performed prior to re-explorative surgery in 26 of 27 patients, which resulted in successful placement in 21. Invasive procedures, selective vein catheterization, and/or arteriography were effective in 12 of 15 patients. Noninvasive procedures, including thallium-technetium scintigraphy, magnetic resonance imaging, computed tomography, and ultrasonography, were accurate in 14 of 21 patients. Twenty-three (85%) of 27 patients were cured, including 17 of 20 patients after an unsuccessful initial exploration and 6 of 7 patients with recurrent disease. Careful review of operative and pathology reports from the initial surgery was essential in determining the adequacy of the exploration, the presence of microscopic abnormalities, and the glands that were positively identified. Such analysis, in conjunction with noninvasive localization studies, will lead to successful re-exploration in the majority of cases.

Preoperative parathyroid localization with sestamibi.

PURPOSE: Results of noninvasive preoperative parathyroid localization with technetium99m-labeled sestamibi are reported in a series of 51 patients. PATIENTS AND METHODS: Forty-four patients had hyperparathyroidism surgically treated for the first time and seven patients underwent reexploration for recurrent or persistent hyperparathyroidism. Preoperative scintigraphy with sestamibi was performed in all patients before surgical exploration. Results of the radionuclide studies were compared with surgical and pathologic findings. RESULTS: Twenty-six patients had solitary adenomas. All 26 were localized preoperatively by the scans. Among 18 patients with multiglandular pathology, 69 pathological glands were found at surgery. Thirty-six of these glands, in 15 patients, were localized by the scans. Among the 7 patients evaluated after failed exploration or recurrent hyperparathyroidism, 7 pathologic glands were found, of which 6 were correctly localized by the scan. Ectopic lesions in 2 patients were correctly localized by the scan. CONCLUSIONS: The authors conclude that sestamibi parathyroid localization is an effective method for preoperative parathyroid localization, with accuracy exceeding that of other noninvasive studies.

Fine-needle aspiration of parotid tumors.

We evaluated the accuracy and usefulness of fine-needle aspiration cytologic evaluation of intraparotid masses in 64 patients who underwent subsequent surgery. Adequate specimens for cytologic evaluation were obtained in 46 of the 64 patients (72 percent). Thirty-three lesions in this group (72 percent) were benign and 13 (28 percent) were malignant. There was agreement of cytologic with final histologic diagnosis with regard to distinction of malignant from benign lesions in 43 of the 46 cases (93 percent). Eleven of 13 malignant tumors (sensitivity 85 percent) and 32 of 33 benign lesions (specificity 97 percent) were predicted. Exact tissue diagnosis was correctly determined in 34 of the 46 tumors (74 percent). There were no instances of hematoma, infection, facial nerve injury, implantation of tumor, or other complications as a result of 71 aspirations performed in 64 patients. Information gained by fine-needle aspiration was often valuable in assessing the suitability and extent of surgical treatment.

Needle aspiration biopsy of thyroid nodules.

Needle aspiration biopsies for cytology were performed on 224 patients with thyroid nodules. Diagnosis was confirmed by surgical exploration in 134 patients. Twenty-four biopsies were reported positive for malignancy; 23 were confirmed at operation and there was 1 false positive. Forty-one biopsies were reported benign. Three of these lesions were found to be malignant, representing false negatives. Sixty-nine biopsies were in the questionable category; 16 (23%) of these were malignant. None of the patients suffered complications from the biopsies. Routine employment of needle aspiration biopsy on our service has resulted in a marked increase in the incidence of carcinoma in thyroid nodules selected for surgery. This has resulted from detection of otherwise unsuspected malignancy, as well as avoidance of surgery in patients with benign lesions. Needle aspiration is not a substitute for surgery. It is a valuable diagnostic procedure, and should be performed in the evaluation of essentially all thyroid nodules. We continue to use radioiodine scanning to evaluate our patients, but have found the routine use of ultrasonography unnecessary when needle aspiration is employed. The ultimate decision regarding surgical exploration is based on a combination of factors including history, physical findings, radioiodine scan and needle aspiration biopsy.

Replacement of upper esophagus: results with myocutaneous flap and with gastric transposition.

The authors reviewed 25 cases of pharyngoesophageal replacement. A tubed pectoralis major myocutaneous flap was employed in ten cases where an adequate distal resection margin could be obtained above the thoracic inlet. Total gastric transposition was used in 15 cases where resection extended into the mediastinum. The overall rates of complications (52%), postoperative mortality (20%), and satisfactory deglutition (80%) were similar for both operations and were superior to those achieved with reconstructive procedures previously used by the authors. The choice of method is influenced by the length of the pharyngoesophagus to be replaced and the general condition of the patient. Gastric transposition is a more versatile operation and is adaptable to replacement of the entire esophagus if necessary, while the tubed pectoralis major myocutaneous flap has proven particularly effective for the rehabilitation of elderly and severely debilitated patients.

Prototype airway management system for use during laser surgery.

A Norton metal endotracheal tube with a Merav parachute cuff cemented to the distal end has solved many of the problems involved in administration of anesthesia for laser surgery of the upper aerodigestive tract. The tube is fireproof and provides an air-tight seal for positive pressure ventilation without the impediment of a cuff channel. It is ideal for laser surgery of the oral cavity and pharynx and may be used effectively for glottic lesions in many instances.

Cervical cysts: cancer until proven otherwise?

A cystic neck mass can be either malignant or benign; 22% of patients (4/18) admitted with the tentative diagnosis of branchial cyst in a recent 2-year period (1977-1979) had metastatic carcinoma: epidermoid, thyroid or salivary gland. Preoperative fine needle aspiration was diagnostic in 1 instance and unhelpful in 2. Frozen section analysis of the gross specimen invariably provided the correct diagnosis. All patients with malignancies had subclinical primary disease and in 1 instance random biopsies identified its origin. The prudent surgeon will avoid untoward results if he approaches a neck cyst in an adult as if it were malignant. Guidelines he can follow to prevent the inadvertent removal of a metastasis under the misapprehension that it is a benign neck cyst include: 1. Prior to operation, perform a thorough head and neck examination to identify a primary carcinoma; 2. Do a fine needle aspiration of the mass for cytology. A negative report must be considered inconclusive; 3. Make a gross examination in the operating room of the opened cyst and frozen section processing of suspicious areas; 4. Follow with a panendoscopy and random biopsies of appropriate areas and complete the neck dissection on the involved side, after a metastatic deposit has been recognized. The preoperative procurement of contingency consent for these procedures is understood.

Kaposi's sarcoma of the parotid gland in acquired immunodeficiency syndrome.

Parotid gland enlargement is common in patients infected with the human immunodeficiency virus. Although parotitis is the usual histopathological feature in such cases, patients with acquired immunodeficiency syndrome are at high risk of developing both lymphoma and Kaposi's sarcoma of the parotid gland. Human immunodeficiency virus, however, is not detected within the parotid parenchyma even in the presence of Kaposi's sarcoma. The pathway of the virus' entry into the saliva remains unknown.

The parasternal paddle: a modification of the pectoralis major myocutaneous flap.

A modification of the pectoralis major myocutaneous flap has been described for head and neck reconstruction. The flap uses the skin overlying the sternum and parasternal area and may extend across the midline to the contralateral internal mammary perforators. The flap has been uniformly reliable in our experience. It is thin and easy to elevate, and donor-site morbidity is minimal. This flap is rapidly becoming our first-choice for head and neck reconstruction.

Cartilaginous tumors of the larynx.

Cartilaginous tumors of the larynx, while rare, will on occasion be encountered by the otolaryngologist in routine daily practice. True laryngeal chondromas are exceedingly rare, and as a consequence, a putative diagnosis of chondroma should be viewed with suspicion. On pathologic examination, laryngeal chondromas usually prove to be small lesions (less than 2 cm in maximum dimension) and may arise in children or adults. Laryngeal chondrosarcomas, by contrast, usually prove to be larger lesions (exceeding 3 cm in greatest dimension) and are typically found in adults. While high-grade chondrosarcomas are readily identifiable on light microscopic study, the distinction between a chondroma and a low-grade chondrosarcoma is often not so clear-cut. Some low-grade chondrosarcomas may show a slight increase in both cellularity and cytologic atypia when compared with chondromas, but the two patterns often overlap. When faced with a limited biopsy specimen of a laryngeal cartilaginous lesion in which neither increased cellularity nor recognizable cytologic atypia is found, a diagnosis of "cartilaginous tumor without obvious evidence of malignancy--further classification dependent on examination of the lesion in its entirety," or words to this effect, is recommended.

Laryngeal paraganglioma versus atypical carcinoid tumor.

Paraganglioma and atypical carcinoid tumor of the larynx are two neuroendocrine neoplasms that have often been confused in the past, and even in the present, in the literature. The clinicopathological profile of the two lesions is presented and the differential diagnosis is discussed. A correct diagnosis is of paramount importance, since treatment and prognosis depend on diagnostic accuracy and differ for the two lesions. Paraganglioma of the larynx is usually benign, whereas atypical carcinoid tumor is malignant and has an aggressive clinical course.

The role of partial laryngeal resection in current management of laryngeal cancer: a collective review.

A spectrum of treatment plans and surgical procedures is available for management of early and moderately advanced laryngeal cancer. While the approach of chemotherapy and irradiation, or irradiation alone, followed by total laryngectomy for failure is often employed in practice by present day clinicians, the options of conventional conservation surgery (CCS), transoral endoscopic laser surgery (TLS) and supracricoid partial laryngectomy (SCPL) provide a wide choice of treatments that may help attain the goal of cure with preservation of laryngeal function and integrity of the airway. While CCS has been supplanted for many early-stage lesions by TLS and for more advanced stages by SCPL, centres throughout the world have reported favourable results with CCS, which is often modified to include resection of more extensive tumours than was previously possible. During the past decade a number of extended CCS procedures have been developed for management of glottic tumours involving both vocal cords and the anterior commissure, the paraglottic space and with vocal cord fixation, and for supraglottic tumours involving the glottis or hypopharynx. TLS has proved an effective, minimally invasive and functionally satisfactory procedure for management of suitable T1 and T2 glottic cancers, and stage I-III supraglottic cancers. The procedure may be effectively employed in combination with neck dissection and postoperative radiotherapy when necessary, particularly for moderately advanced supraglottic carcinomas. SCPL has proven effective in management of glottic and supraglottic cancers of all stages, even with involvement of paraglottic space and thyroid cartilage, provided at least one arytenoid unit can be preserved with clear margins. Invasion of cricoid cartilage is the most significant limitation for this procedure. All three surgical approaches have been employed for irradiation failure, but with greatly increased failure and complication rates compared with the results of treatment of non-irradiated patients. Thus a decision to treat laryngeal cancer initially with irradiation may preclude a satisfactory result from partial laryngectomy should radiation fail. The treatment of laryngeal cancer should be individualized according to the size and extent of the tumour, the age and physical condition of the patient, and the skill and experience of the surgeon with various treatment modalities and surgical procedures.

Surgical approach to submucosal lesions of the supraglottic larynx: the supero-lateral thyrotomy.

The surgical approach to the hypopharynx by lateral pharyngotomy as described by Trotter has found widespread use in management of supraglottic carcinoma. A similar but more conservative approach may be employed for removal of cysts and benign or well-encapsulated neoplasms of the epiglottis and supraglottic space. We call this approach a supero-lateral thyrotomy, to differentiate it from the classic lateral pharyngotomy. Surgery consists of subperichondrial resection of the superior half of the ipsilateral thyroid cartilage with preservation of internal lining and superior laryngeal nerve. The lesion may then be enucleated or resected, and the defect, if any exists, closed with overlying mucosa and the flap of preserved perichondrium. The technique has been employed in cases of paraganglioma, haemangiopericytoma and saccular cysts.

Schwannoma of the cervical sympathetic chain.

Two cases of schwannomas of the cervical sympathetic chain (CSC) are described. Eleven clearly documented cases have been described in the previous literature. These tumours are usually solitary, asymptomatic cervical masses that occur within the upper carotid sheath or parapharyngeal space. The lesions tend to be hypervascular, but not to the same extent as chemodectomas. Angiography may be employed for differential diagnosis. Schwannomas of the CSC are usually readily excised by a cervical approach. Horner's syndrome is a frequent post-operative sequel, despite anatomical preservation of the sympathetic chain. This neurological impairment is usually asymptomatic. Recurrences and malignant degeneration rarely occur.