Endoscopic Injection of Mitomycin C for the Treatment of Pharyngoesophageal Stenosis

NCT03540953 | Terminated

• 1 other identifier: NP549/14
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Management of pharyngoesophageal stenosis (PES) in patients after head and neck cancer (HNC) treatment remains a challenge. There are some cases of strictures refractory to dilation sessions. This study aimed to evaluate the efficacy of Mitomycin C (MMC) endoscopic injection for the treatment of refractory pharyngoesophageal stenosis. Patients and methods: This is a prospective study in patients with dysphagia following head and neck cancer treatment, without evidence suggestive of tumor recurrence, and refractory to endoscopic treatment. Theses undergo endoscopic dilation of the stenotic segment with thermoplastic bougies, followed by the injection of MMC.

Conditions

Esophageal Stenosis; Deglutition Disorders; Head and Neck Neoplasms; Esophageal Neoplasms

Keywords

Endoscopic injection of Mitomycin C

Outcome Measures

Primary Outcomes (1)

• dysphagia

  dysphagia score (0 = able to eat normal diet / no dysphagia;1 = able to swallow some solid foods; 2 = able to swallow only semi solid foods; 3 = able to swallow liquids only; 4 = unable to swallow anything / total dysphagia)

  2 years

Secondary Outcomes (1)

• number of sessions of endoscopic dilations

  2 years

Study Arms (1)

Endoscopic injection of Mitomycin C

OTHER

Endoscopy injection of Mitomycin C will be perform to the treatment of pharyngoesophageal stenosis refractory to endoscopic treatment with dilatation in patients with head and neck cancer

Drug: Endoscopic injection of Mitomycin C

Interventions

Endoscopic injection of Mitomycin C DRUG

administration included dilation of the stenotic segment with thermoplastic bougies, followed by the injection of 3mg of Mitomycin C, divided into 4 aliquots of 0.75mg, injected in the four quadrants, at the stenosis level.

Endoscopic injection of Mitomycin C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with dysphagia following head and neck cancer treatment
• Patients without endoscopic or radiological evidence suggestive of tumor recurrence
• Patients refractory to endoscopic treatment

You may not qualify if:

• Endoscopic or radiological signs suggestive of tumor recurrence

Sponsors & Collaborators

• Fauze Maluf Filho: lead

Study Sites (1)

Instituto do Câncer do Estado de São Paulo - ICESP

São Paulo, 01246-000, Brazil

Location

MeSH Terms

Conditions

Esophageal Stenosis; Deglutition Disorders; Head and Neck Neoplasms; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: May 30, 2018
• Study Start: January 5, 2015
• Primary Completion: May 5, 2015
• Study Completion: January 5, 2018
• Last Updated: May 30, 2018

Record last verified: 2018-03

Locations

BR (1)