CTRI Number	CTRI/2018/05/014337 [Registered on: 31/05/2018] Trial Registered Retrospectively
Last Modified On:	12/03/2024
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Surgical/Anesthesia
Study Design	Randomized, Parallel Group Trial
Public Title of Study	use of muscle flap in reducing leak rate after radiation therapy and surgery for larynx cancer
Scientific Title of Study	Utility of pectoralis major myofascial flap in reducing pharyngocutaneous fistula rates after salvage total laryngectomy
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Dr. Gouri Pantvaidya  Address  Tata Memorial Hospital, Room No. 202, 2nd Floor, Homi Bhabha Block, Tata Memorial Hospital, Dr. E Borges Road Parel East Mumbai, Maharashtra. 400012. India Mumbai MAHARASHTRA 400012 India  Phone  022241770006212   Fax     Email  docgouri@gmail.com
Details Contact Person Scientific Query Modification(s)	Name  Dr. Gouri Pantvaidya  Address  Tata Memorial Hospital, Room No. 202, 2nd Floor, Homi Bhabha Block, Tata Memorial Hospital, Dr. E Borges Road Parel East Mumbai, Maharashtra. 400012. India Mumbai MAHARASHTRA 400012 India  Phone  022241770006212   Fax     Email  docgouri@gmail.com
Details Contact Person Public Query Modification(s)	Name  Dr. Gouri Pantvaidya  Address  Tata Memorial Hospital, Room No. 202, 2nd Floor, Homi Bhabha Block, Tata Memorial Hospital, Dr. E Borges Road Parel East Mumbai, Maharashtra. 400012. India Mumbai MAHARASHTRA 400012 India  Phone  022241770006212   Fax     Email  docgouri@gmail.com
Source of Monetary or Material Support Modification(s)	Tata Memorial Hospital, Dr. E. Borges Road, Parel -400012
Primary Sponsor	Name  Tata memorial hospital  Address  Dr. E Borges Road, Parel, Mumbai  Type of Sponsor  Government funding agency
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 7   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Kapil Sikka  AIIMS(All India Institute Of Medical Sciences)  ENT Department, 6th Floor, New RAK OPD, AIIMS New Delhi East   9810423088 kapil_sikka@yahoo.com  Dr Anupam Das  Dr. B. Borooah Cancer Institute  Room no 107,1st Floor, OPD building, Head & Neck, Dr. B Borooah Cancer Institute, Gopinath Nagar, Ghy-16., Guwahati 781016 Kamrup   9435115437 anupamdasgmc@gmail.com  Dr Sasikrishna Kavutharapu  Homi Bhabha Cancer Hospital & Research Centre  Marripalem, Aganampudi Village, Gajuwaka Mandalam, NH16, Visakhapatnam, Andhra Pradesh 530053 Visakhapatnam   9560449894 sasi7asram@gmail.com  Dr Parag Watve  Kolhapur Cancer centre  R.S. 238 Opp. Mayur Petrol Pump , Gokul Shirgaon Kolhapur, 416234. Kolhapur   8380010583 paragwatve@gmail.com  Dr Aseem Mishra  Mahamana Pandit Madan Mohan Malviya Cancer  Ground floor D &T Block Head and Neck OPD 26,Mahamana Pandit Madan Mohan Malviya Cancer Centre, Varanasi Banaras Hindu University, Campus, Sundar Bagiya, Colony, Sundarpur, Varanasi, Uttar Pradesh 221005 Varanasi   8080611946 draseemmishra@gmail.com  Dr Harsh Dhar  Medica Superspeciality Hospital  Medical Superspecialty Hospital, 127, Eastern Metropolitan Bypass, Nitai Nagar, Mukundapur, Kolkata, West Bengal 700099 Kolkata   9757323446 xavodoc2003@gmail.com  Dr Gouri Pantvaidya  Tata Memorial Hospital  Tata Memorial Hospital, Room No. 202, 2nd Floor, Homi Bhabha Block, Tata Memorial Hospital, Dr. E Borges Road Parel East Mumbai, Maharashtra. 400012. India Mumbai   9833971155 docgouri@gmail.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 7   Name of Committee  Approval Status  Clinical Research Ethics Committee  Approved  HBCH RC Ethics Committee  Approved  Institute Ethics Committee  Approved  Institutional Ethics Committee  Approved  Institutional Ethics Committee,  Approved  KCC Institutional Ethics Committee  Approved  Medical Ethics Committee  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Patients  Patients suffering from laryngeal cancer
Intervention / Comparator Agent	Type  Name  Details  Intervention  PMMF ARM  All previously treated patients of larynx and hypopharynx carcinoma with biopsy proven recurrence / residual disease, suitable for salvage total laryngectomy and primary closure as decided by the disease management Group (DMG) will be enrolled. After the consent process patient will be subjected to surgery and intraoperative randomization would be done after decision for primary closure has been made. Stratification will be done based on site. In intervention arm,patient will undergo salvage total laryngectomy with primary closure and onlay PMMF  Comparator Agent  STANDARD ARM  All previously treated patients of larynx and hypopharynx carcinoma with biopsy proven recurrence / residual disease, suitable for salvage total laryngectomy and primary closure as decided by the disease management Group (DMG) will be enrolled. After the consent process patient will be subjected to surgery and intraoperative randomization would be done after decision for primary closure has been made. Stratification will be done based on site. On STD arm PATIENTS will be comprised of total laryngectomy with primary closure.
Inclusion Criteria Modification(s)	Age From  18.00 Year(s) Age To  70.00 Year(s) Gender  Both  Details  1-Recurrent / residual lesions irrespective of histology of larynx and hypopharynx previously treated with radiotherapy/ chemoradiotherapy undergoing salvage total laryngectomy. 2-Patients in whom primary pharyngeal closure is possible with no need for pharyngeal reconstruction to augment pharyngeal mucosa closure. 3- Patients with age between 18 years -70 years 4- Patients with dysfunctional larynx as deemed by the tumor board decision with negative histopathology report. Dysfunctional larynx may include: persistent tracheostomy, chondronecrosis, persistent nasogastric tube use, and aspiration
ExclusionCriteria	Details  1-Treatment naive patient with no prior radiotherapy/chemo-radiotherapy. 2-Patients suitable for conservation laryngeal surgery. 3-Patients requiring pharyngeal reconstruction for pharyngeal mucosa closure in whom primary pharyngeal closure not possible.
Method of Generating Random Sequence	Stratified randomization
Method of Concealment	Not Applicable
Blinding/Masking	Open Label
Primary Outcome Modification(s)	Outcome  TimePoints  To assess the utility of pectoralis major myofascial flap in reducing pharyngocutaneous fistula rates after salvage total laryngectomy.   At the end of completion of treatment
Secondary Outcome Modification(s)	Outcome  TimePoints  To identify factors affecting pharyngocutaneous fistula in salvage total laryngectomy.  At the end of completion of treatment
Target Sample Size	Total Sample Size="160" Sample Size from India="160"
Phase of Trial	Phase 3
Date of First Enrollment (India) Modification(s)	18/06/2015
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="7" Months="0" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Open to Recruitment
Publication Details Modification(s)	NA
Brief Summary Modification(s)	In today’s era of organ preservation total laryngectomy is reserved for advanced cases with dysfunctioning larynx.  An increasing number of cancers of the larynx and hypopharynx are treated by nonsurgical organ preservation protocols. This has resulted in an increase in the number of salvage laryngectomy over the last two decade. Prior radiation / chemoradiation has been known to be associated with significant postoperative morbidity namely pharyngocutaneous fistula.Pharyngocutaneous fistula is a troublesome complication following total laryngectomy prolonging hospital stay and sometimes requiring second surgery, thereby increasing cost of treatment significantly. Fistula rates in salvage settings are variable and reported between 14-61% in contrast to that of in primary setting which is reported to be in the range of 14-20 % in most series. In an effort to decrease the leak in salvage settings some authors have advocated reinforcing the suture line using onlaypectoralis major myofascial flap (PMMF). Rationale behind using onlay PMMF is providing the non-irradiated vascularized tissue over a suture line which is considered to be hypoxic and relatively sparse in micronutrients as a result of prior radiotherapy. However literature is divided as to whether a prophylactic flap to augment the suture line would help decrease the fistula rates. There is a paucity of adequate data in this regard. Though the recent meta-analysis published favors use of onlay PMMF, it has considerable heterogeneity and has included mainly retrospective series and observational studies with small number of patients. Thus there is a need to conduct a prospective study to answer this question.