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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypopharyngeal Carcinoma

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Italy
  • Lombardy
    • Pavia, Lombardy, Italy, 27100
      • Fondazione IRCCS Policlinico San Matteo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with recurrence of hypopharynx/hypopharyngolarynx cancer after salvage surgery

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the difference in proportions of non necrotic complications in the two groups of patients.	up to 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
the difference in proportions of necrotic complications in the two groups of patients.	up to 24 months

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2025
• Primary Completion (Estimated): March 18, 2027
• Study Completion (Estimated): March 18, 2027

Study Registration Dates

• First Submitted: December 3, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Hypopharyngeal Neoplasms
• Other Study ID Numbers: Salvage_reconstruction

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No