RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE.
KARNATAKA
Annexure -1
PROFORMA FOR THE REGISTRATION OF SUBJECTS FOR DISSERTATION
1. / Name of the candidate and address[ in block letters] / DR. SAMAR BAKHT
POST GRADUATE STUDENT
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY,
D.A.PANDU MEMORIAL R.V.DENTAL COLLEGE AND HOSPITAL,
BANGALORE.
2 / Name of the institution / D.A.PANDU MEMORIAL R.V. DENTAL COLLEGE,
BANGALORE -560 078
KARNATAKA
3. / Course of study and subject / MASTER OF DENTAL SURGERY IN
ORAL AND MAXILLOFACIAL SURGERY
4. / Date of admission to course / 01-06-2012
5. / Title of the topic / TO EVALUATE THE EFFICACY OF SUPRAOMOHYOID NECK DISSECTION AS COMPARED TO FUNCTIONAL NECK DISSECTION IN PATIENTS WITH SQUAMOUS CELL CARCINOMA OF ORAL CAVITY-:A CLINICAL, RADIOLOGICAL AND PATHOLOGICAL STUDY OF 100 CONSECUTIVE CASES
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12. / 6.1: Need For The Study:-
· Oral squamous cell carcinoma (OSCC) is currently the 10th most common human malignancy worldwide affecting about 300,000 individuals per year1.
· The incidence of occult cervical lymph node metastasis in patients with oral squamous cell carcinoma varies from 6% to 85%.The presence of cervical metastasis in patients with OSCC is the most important critical factor in determining survival2.
· The major therapeutic strategy for early node negative OSCC comprises the surgical resection of the primary tumour with clear margins and reconstruction with local or free-flaps.
· The treatment of the clinical N0 neck, however, is still the subject of ongoing discussion since OSCC has an unpredictable capacity to create occult metastases in the loco-regional lymph nodes in up to 20% of all patients1.
· Several histopathologic parameters, such as tumour depth, grade of differentiation and lymphatic invasion have been suggested as predictor of occult metastases in node-negative OSCC.
· To address the risk of cervical lymph node metastases, head and neck cancer patients historically have frequently been treated with classical radical neck dissection.
· This well-established surgical procedure involves the resection of the ipsilateral lymph nodes of level I-V,submandibular salivary gland, internal jugular vein, spinal accessory nerve and sternocleidomastoid muscle. Although it is a safe oncological surgical procedure reducing the risk of regional recurrences, it produces multiple postoperative functional and cosmetic deformities.
· To reduce morbidity, more selective surgical approaches such as Modified Radical neck dissection, Functional neck dissection, Supraomohyoid neck dissection were developed.
· For the treatment of the clinically N0& selected N+ necks with limited nodal disease, selective supraomohyoid neck dissection has assumed increasing importance as a safe and potential curative surgical procedure with low morbidity to address the risk of occult metastases in oral cavity cancer.
· As compared to classical radical neck dissection, Functional neck dissection is as effective in controlling metastatic squamous cell carcinoma in patients with no clinical evidence of metastasis or with early metastasis and is associated with low incidence of functional morbidity The purpose of this study is to evaluate the efficacy of Supraomohyoid neck dissection as compared to Functional neck dissection in patients with Oral Squamous Cell Carcinoma.
· Our evaluation parameters include survival probabilities, neck recurrences and distant metastases which will be evaluated over a period of 12 months.
6.2.Review of literature:
1.Thiele O.C1 et al conducted a study in 2011 to assess whether elective supraomohyoid neck dissection is reasonable and efficient in early, locally circumscribed OSCC in which the outcomes of 122 patients with an OSCC of clinical UICC stage I or II were retrospectively analysed.Occult metastases were detected in 13.9%(17/122) of cases. They were more frequently found in T2 comparedto T1tumours (19 %{14/71} vs.5.9 %{3/51},p=0.03), age, gender, grading had no influence on the prevalence of occult lymph node metastases. He concluded that elective supraomohyoid neck dissection detects occult metastases in early, node-negative OSCC and in patients with early OSCC exhibiting occult metastases should be considered as high risk patients, warranting additional therapeutic regimes.
2.In the year2005 Yu S2 et al conducted a retrospective comparison which aimed to assess oncologic results obtained with the use of supraomohyoid neck dissection as compared to radical neck dissection in 455 patients with oral squamous cell carcinoma and N0neck.He found no significant difference between patients treated with SOHND versus RND. The variable parameters such as occult metastases rate, regional disease-free survival, overall and disease-free survival rates were found to be comparable. Thus he concluded that SOHND compares favorably with RND for the staging and treatment of patients with squamous cell carcinoma and negative neck.
3.Another review of the work done by SpiroRH, ShahJP8in 1996in patients with oral SCC found that of 248 cases of elective SOHND, clinically negative nodes proved histologically positive in 60 patients(25%), only 4 of whom failed in the neck(7%).A total of 48 patients(16%) had therapeutic SOHND for limited N+ disease, confirmed pathologically in 31, with a neck recurrence documented in 2(6%).They concluded that SOHND is a reliable staging procedure in patients with N0 oral or oropharyngeal SCC.
4.In another series of work done by Majoufre C et al3 in 1999 in 237 previously untreated patients with oral cavity cancer who underwent either Supraomohyoid neck dissection or Functional neck dissection as neck treatment.He found that 5-year survival probabilities for patients treated with SOHND was 70.2% & 76.5% in N0 and N1 necks respectively and concluded that SOHND is an effective method of treatment for the clinically negative necks in patients with squamous cell carcinoma of the oral cavity.
5.In 1998 Bertani RR et al4 conducted a prospective trial on elective radical classical versus supraomohyoid neck dissections in 148 patients with oral squamous cell carcinoma. He found that false negative rates were 28% and most positive nodes were sited at levels I & II. Complication rates were 41% and 25% in MRND and SOHND patients respectively.Further he noted that the 19 and 16 patients presented with local and regional recurrences respectively .This led him to conclude that recurrence and survival rates were similar in both MRND and SOHND groups and that SOHND can be recommended as standard elective treatment for patients with T2-T4 oral squamous cell carcinoma.
6.3Aim and Objectives Of The Study:
Aim:
· To evaluate the efficacy of Supraomohyoid neck dissection in comparison with Functional neck dissection in patients with Squamous Cell Carcinoma of Oral Cavity.
Objective:
· To review the efficacy of supraomohyoid neck dissection as compared to functional neck dissection in 100 patients with squamous cell carcinoma of oral cavity through clinical, radiological and histological evaluation.
Materials And Methods:
7.1 Materials-:
· A total sample size consisting of 100 patients with diagnosed squamous cell carcinoma of oral cavity and secondary lymph nodes involved are included in the study.
7.2 Method-:
· A prospective study sample consisting of a total 100 patients (50 SOHND and 50 FND) requiring treatment of head and neck cancer. Staging of the primary tumour and neck nodes will be done according to the 1992 TNM Classification System as recommended by Union Internationale Contre le Cancer (UICC).Pretreatment staging evaluation will include clinical examination, chest radiography andultrasound sonography/computed-tomography(CT) scan/magnetic resonance imaging (MRI)/positron emission tomography(PET)of the head and neck region, and further staging procedures, if indicated.
· Hematological and biochemical laboratory tests, electrocardiogram and biopsy of the primary tumour will be routinely performed in all cases. A signed informed consent will be taken before starting the treatment. Patients will be lateralized(unilateral/bilateral) and subsequently randomized to supraomohyoid neck dissection and functional neck dissection (with preservation of sternocleidomastoid muscle, internal jugular vein, spinal accessory nerve)
SOHND GROUP-:
· Supraomohyoid neck dissection will be performed to achieve a compartmental excision of levels I, II, and III neck lymph nodes. The unilateral dissection will be performed through an apron-like incision from the mastoid to the mandibular symphysis, and the bilateral dissection through an incision from mastoid to mastoid overlying the hyoid bone. Flaps will be elevated with preservation of the greater auricular nerve and the external jugular vein. The fascia will be incised along the anterior border of the sternomastoid muscle. The muscle will be retracted and the dissection will continue toward the level of its posterior border with preservation of cutaneous branches of cervical plexus (the posterior limit of the operation). The accessory nerve will be carefully dissected and preserved. The first part of the dissection will begin at the level of the omohyoid muscle intersection with the internal jugular vein. The dissection will then be carried along the jugular vein, carotid arteries, and vagus nerve from the inferior limit of operation to the subdigastric level. All fibroadipose tissue and lymphatics sited over the accessory nerve will be included in the specimen. The dissection will continue through the submandibular triangle and end at the submental area similarly to a classical neck dissection. During the operation all lymph nodes suspected to be metastatic will be submitted to frozen section histologic study. Whenever a positive node will be confirmed during the procedure, the operation will be converted to a functional neck dissection with internal jugular vein, accessory nerve and sternocleidomastoid muscle preservation. The indications and technique of postoperative irradiation are similar to those for the MRND group.
FND GROUP-:
· Fuctional neck dissection involves resection of lymph nodes from level I-V with preservation of non-lymphatic structures such as spinal accessory nerve, internal jugular vein and sternocleidomastoid muscle. Elevating skin and platysma from the outer fascia. The surgical field will be extended from the clavicle to the mandible and mastoid and from the thyroid cartilage to the anterior border of the trapezius The external jugular vein will be skeletonized from the inferior parotid pole to the supraclavicle. Greater auricular nerve will be isolated until it enters the inferior parotid pole; transverse cervical nerve will be isolated until it enters platysma andskin. The spinal accessory nerve will be isolated throughout its course until it enters the sternomastoid and the trapezius. Supraclavicular nerve will be isolated until it enters the supraclavicular edge. The fascia covers the outer aspect of the sternomastoid muscle and omohyoid muscle will be separated by means of sharp dissection. The internal jugular vein will be skeletonized around its whole circumference. Finally, the neck dissection specimen except those preserved tissues will be removed completely.
7.4 SOURCES OF DATA-:
· Patients consulting Department of Oral and Maxillofacial Surgery, D.A Pandu Memorial R.V Dental College, Bangalore and Bangalore Institute Of Oncology and Health Care Global Hospitals and Rangadore Memorial Hospital, Bangalore seeking treatment of head and neck cancer.
7.5 INCLUSION CRITERIA-:
} Patients with clinical and histopathological diagnosis of squamous cell carcinoma of lip, tongue, gingivo-buccal complex, floor of the mouth, retro-molar trigone, palate and maxilla.
} Patients with no previous history of surgery, radiotherapy and/or chemotherapy.
} Patients who are voluntarily willing to come for a minimum of 12 months of follow-up.
} Patients willing to give informed consent for the surgical neck dissection as a treatment protocol for OSCC.
} Patients of all age groups and both sexes.
7.6 EXCLUSION CRITERIA-:
} The presence of underlying systemic diseases.
} Patients with previous history of surgery, radiotherapy and/or chemotherapy.
} Patients unwilling to commit to a long-term post therapy and maintenance programme.
7.3 Does the study require any investigations or interventions to be conducted on patients or other human or animals? If so, please describe briefly.
Yes. Investigations and interventions to be conducted on patientsare
1) Routine blood investigations which include Clotting time, bleeding time and Differential Blood count and biochemical investigations.
2) Pre-operative, Intra-operative and post-operative clinical photographs.
3) Orthopantomographs, Chest radiographs and Ultasonographs/Computed tomographs (CT) Magnetic Resonance Images (MRI)/Positron Emission Tomographs (PET) Of head and neck, if indicated, taken preoperatively and post operatively during follow up.
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
Yes, ethical clearance has been obtained from our institution in case of 7.3
LIST OF REFERENCES:
1. Thiele OC, Seeberger R, Flechtenmacher C, Hofele C, Freier K. The role of elective supraomohyoid neck dissection in the treatment of early node-negative oral squamous cell carcinoma(OSCC):A retrospective analysis of 122 cases. J CraniomaxillofacSurg 2012;40:67-70.
2. Yu S, Li J, Li Z, Zhang W, Zhao J. Efficacy of supraomohyoid neck dissection in patients with oral squamous cell carcinoma and negative neck. Am J Surg 2006; 191:94-99
3.Majoufre C, Faucher A, Laroche C, DeBonfils C, Siberchicot F et al. Supraomohyoid neck dissection in cancer of oral cavity. Am J Surg 1999;178:73-77.
4. Brentani R, Kowalski L, Soares J, Torloni H, Pereira R et al. Results of a prospective trial on elective modified radical neck versus supraomohyoid neck dissection in management of oral squamous carcinoma. Am J Surg 1998;176:422-27.
5. Minghua G, Zhiyuan G, Zhun J, Han C. Modified functional neck dessiction: a useful technique for oral cancer. Oral Oncology 2005;45:978-83.
6. Schiff B, Roberts D, Naggar A, Garden A, Myers J. Selective versus modified radical neck dissection and post operative radiotherapy versus observation in treatment of squamous cell carcinoma of oral tongue. Arch Otolaryngol Head Neck Surg 2005;131:874-78.
7. Jalisi S. Management of clinically negative neck in early squamous cell carcinoma of oral cavity. OtolaryngolClin N Am 2005;38:37-46.
8. Spiro R, Morgen G, Strong EW, Shah JP. Suoraomohyoid neck dissection. Am J Surg 1996;172:650-53.
9. Pathak KA, Das Ak, Agarwal R, Talole S, Deshpande MS, Chaturvedi P et al. Selective neck dissection (I-III) for node negative and node positive necks. Oral Oncology 2006;42:837-41.
10. Rapoport A, Ortellado DK, Amar A, Lehn CN, Dedivitis RA, Perez RS et al. Radical versus supraomohyoid neck dissection in the treatment of squamous cell carcinoma of the inferior level of the mouth. Bras J Otorrinolaringol 2007;73(5):641-46.
Signature of candidate:-
Remarks of the guide:-
Recommended
Name and designation :-
11.1 Guide :
DR. SUNIL VASUDEV
MDS,
PROFESSOR,
DEPARTMENT OF ORAL & MAXILLOFACIAL
SURGERY,
D. A.P.M.R.V DENTAL COLLEGE, BANGALORE
11.2 Signature:
( DR. SUNIL VASUDEV )
11.3Head of the Department:-
DR. S. GIRISH RAO,
MDS, FDSRCS, FFDRCSI
PROFESSOR AND HEAD,
DEPARTMENT OF ORAL AND MAXILLOFACIAL
SURGERY
D.A.P.M.R.V DENTAL COLLEGE AND HOSPITAL,