Clinical trial · Interventional
Gastric Pull up Versus Free Flap Reconstruction for Laryngo-pharyngeal Defects
Gastric Pull up Versus Free Flaps Reconstruction (Anterolateral Thigh and Radial Forearm Free Flap) for Laryngo-pharyngeal Defects: A Prospective Randomized Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will compare the gastric pull up (GPU) with the free flap \[(specifically, anterolateral thigh (ALT) and radial forearm free flap (RFFF)\] techniques used in the reconstruction of alimentary tracts in patients who require laryngectomy and circumferential pharyngectomy for carcinoma resection. These two interventions will be compared by block randomizing 20 patients based on history of failed chemoradiation to undergo either ALT or RFFF. The primary outcome will be the type and number of postoperative complications. The secondary outcomes will include swallowing function, speech, and quality of life measures along with cancer specific endpoints.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pharyngectomy | — | UNRESOLVED | — |
| Reconstructive Surgical Procedures | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Free Flap Surgery | Procedure | — | UNRESOLVED |
| Gastric Pull Up | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Gastric Pull Up
- description
- Patients randomized to undergo gastric pull up surgical reconstruction of pharyngoesophageal defect.
- interventionNames
- Procedure: Gastric Pull Up
- type
- ACTIVE_COMPARATOR
- label
- Free Flap
- description
- Patients randomized to undergo free flap (anterolateral thigh or radial forearm) surgical reconstruction of pharyngoesophageal defect.
- interventionNames
- Procedure: Free Flap Surgery
Primary outcomes (1)
- measure
- Type and number of postoperative complications
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Willing to provide informed consent, attend follow-up visits and complete questionnaires * Have an Eastern Cooperation Oncology Group (ECOG) performance status of 0-2 * Patients with carcinoma of thyroid, larynx, hypopharynx, or cervical esophagus requiring surgery as a primary treatment modality or after chemoradiation treatment failure * Laryngectomy and circumferential pharyngectomy as recommended by the head and neck tumor board Exclusion Criteria: * Serious medical co morbidities or other contraindications to surgery * Metastatic disease * Pregnant or lactating women * Patients whose clinical circumstances are such that one surgical intervention would be recommended over the other: The cancer extends into the the thorax as seen on pre-operative CT scan. In these patients, the GPU reconstruction is preferred. * Patients who have liver cirrhosis or multiple previous surgeries on the stomach would not be candidates for the GPU and thus will be excluded from the study
References
Publications (0)
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