Clinical trial · Interventional
Balloon Dilation to Permit Complete Endoscopic Ultrasound Staging in Esophageal Cancer
Balloon Dilation of Malignant Strictures to Permit Complete Endoscopic Ultrasound Staging in Esophageal Cancer
- 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)
Despite improvement in treatment-related morbidity and mortality, esophageal cancer is still one of the most lethal malignancies. Accurate staging is essential to establish prognosis and for patient management. Staging helps to determine if surgery, chemotherapy, radiation therapy, a combination of these, or a palliative approach is the most appropriate. Endoscopic ultrasound techniques are becoming more and more popular. At Notre Dame Hospital, Centre Hospitalier de L'Universite de Montreal, all patients diagnosed with esophageal cancer undergo complete EUS staging. In selected patients, EUS is followed by EBUS during the same procedure, in order to examine all the lymph nodes near or far from the primary tumor amenable to EBUS guided trans-bronchial biopsy. In patients with a malignant esophageal stricture, we have preformed very gentle balloon dilation up to 14 mm. It is important to realize that this is not to achieve symptom resolution, but rather to allow the passage of the scope. We hypothesize that earlier reports of higher perforation rates were related to unnecessary aggressive dilation. Thus far, we have successfully dilated over 60 patients during the last four years (2009-2013) and were able to pass the scope and complete the examination in the vast majority of patients with no morbidity.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Balloon dilation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety of gentle dilation
- timeFrame
- 10 months
- description
- Examine the safety of gentle dilation of a malignant stricture to permit a complete endosonographic examination in patients with strictures not allowing passage of the EUS scope. Determine the proportion of patients that could undergo a complete EUS examination after dilation up to a maximum 14 mm.
Secondary outcomes (1)
- measure
- impact on staging
- timeFrame
- 10 months
- description
- Examine the impact on staging gained by completing the EUS examination after dilation compared to the situation of non-dilation (incomplete staging due to non-passage of tumor).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy proven esophageal cancer * Endoluminal esophageal mass without previous biopsy * Medical suitability for endoscopic procedure * Ability to consent Exclusion Criteria: * Patient on Coumadin (Warfarin), Plavix (Clopidogrel) or other anticoagulants with inability to stop medication for 5 days prior to procedure * Tumors so tight that even a pediatric endoscope cannot traverse the stricture
References
Publications (1)
- DERIVEDMolina JC, Goudie E, Pollock C, Menezes V, Ferraro P, Lafontaine E, Martin J, Nasir B, Liberman M. Balloon Dilation for Endosonographic Staging in Esophageal Cancer: A Phase 1 Clinical Trial. Ann Thorac Surg. 2021 Apr;111(4):1150-1155. doi: 10.1016/j.athoracsur.2020.06.063. Epub 2020 Aug 29. PMID 32866480