Salvage Surgery in Recurrent Hypopharyngeal Carcinoma: an Observational Single-institutional Study From 1998

NCT ID: NCT07295561

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-18

Study Completion Date

2027-03-18

Brief Summary

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The aim of this study will be to assess the association between the type of a surgical flap and post-operative complication in patients with hypopharyngeal cancer undergoing salvage surgery (SS) and reconstruction with free or pedicled flaps.

Detailed Description

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Squamous cell carcinoma of the hypopharynx (HPSCC) is a rare but aggressive cancer, accounting for only 3-5% of all head and neck cancers. It occurs in the III-IV stage in about 60-85 % of cases, with 5-year overall survival (OS) ranging from 25 to 41%. It tends to spread in local submucosa, with an early involvement of the larynx and the locoregional tissue. Disease recurrence is around 15% to 40%, depending on the casuistry, the type of primary treatment (surgery vs. organ preservation protocols) and personal experience of each center. In recurrence setting, where indicated, salvage surgery (SS) remains the gold standard with the highest survival rates compared to conservative therapy. Generally patients are frail, with poor performance status and countless comorbidities and between 33% to 66% of cases are eligible to surgery with curative intent. In fact, in salvage setting the risk of peri-operative mortality is higher, postoperative complications are more frequent and hospital stay is longer.

Therefore, a careful selection of candidates is imperative and based on the following criteria: age and comorbidities, site of recurrence, stage, time interval since the first treatment and type of previous therapies

Conditions

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Hypopharyngeal Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* recurrence of hypopharynx/hypopharyngolarynx cancer after the first hypopharynx/hypopharyngolarynx tumor;
* treatment with salvage surgery and reconstruction using free or pedicled flaps.

Exclusion Criteria

* recurrence of cancer in a location other than the hypopharynx/hypopharyngolarynx or with the first tumor in a location other than the hypopharynx/hypopharyngolarynx;
* treatment with salvage surgery without flap reconstruction or with salvage treatment not involving flap reconstruction
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role lead

Responsible Party

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Simone Mauramati

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fondazione IRCCS Policlinico San Matteo

Pavia, Lombardy, Italy

Site Status

Countries

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Italy

Other Identifiers

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Salvage_reconstruction

Identifier Type: -

Identifier Source: org_study_id