NCT07295561

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
10mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Mar 2025Mar 2027

Study Start

First participant enrolled

March 18, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 19, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2027

Last Updated

December 19, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

December 3, 2025

Last Update Submit

December 16, 2025

Conditions

Hypopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

  • the difference in proportions of non necrotic complications in the two groups of patients.

    up to 24 months

Secondary Outcomes (1)

  • the difference in proportions of necrotic complications in the two groups of patients.

    up to 24 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with recurrence of hypopharynx/hypopharyngolarynx cancer after salvage surgery

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Hypopharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 3, 2025

First Posted

December 19, 2025

Study Start

March 18, 2025

Primary Completion (Estimated)

March 18, 2027

Study Completion (Estimated)

March 18, 2027

Last Updated

December 19, 2025

Record last verified: 2025-08

Locations

IT(1)