Clinical trial · Observational
Intrathoracic Esophagogastric Anastomosis After Robot Assisted Minimally Invasive Esophagectomy Using STRATAFIX
NCT02609425CI-TRIAL-00071666completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
Determine the safety and efficacy of novel suture in esophageal anastomosis. Specific Aims: 1) Determine the safety of using STRATAFIX suture in esophagogastric anastomosis by measuring anastomotic leak rate; and 2) Determine efficacy of STRATAFIX suture in esophagogastric anastomosis by measure anastomotic stricture rate.
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 |
|---|---|---|---|
| Stratafix PGA Suture | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- STRATAFIX
- description
- Anastomosis of esophagus to stomach
- interventionNames
- Device: Stratafix PGA Suture
Primary outcomes (1)
- measure
- Anastomotic Leak Rate After Esophagectomy
- timeFrame
- 5-7 Days to assess anastomotic integrity
- description
- Analysis specific to anastomosis leak will be analyzed and compared with historically published results to determine whether Stratafix suture is appropriate in this application.
Secondary outcomes (1)
- measure
- Anastomotic Stricture Rate After Esophagectomy
- timeFrame
- 5-7 days to assess anastomotic integrity
- description
- Analysis specific to anastomosis stricture will be analyzed and compared with historically published results to determine whether Stratafix suture is appropriate in this application.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. All patients with esophageal cancer who are deemed candidates for minimally invasive robot assisted Ivor Lewis esophagogastrostomy. 2. Patients who provide written informed consent for the study. Exclusion Criteria: 1. Any patient with esophageal cancer who is not deemed a surgical candidate or who is not deemed a candidate for the Ivor Lewis technique of esophagectomy (with intrathoracic anastomosis). 2. Any patient less than 18 years of age
References
Publications (2)
- BACKGROUNDCerfolio RJ, Bryant AS, Hawn MT. Technical aspects and early results of robotic esophagectomy with chest anastomosis. J Thorac Cardiovasc Surg. 2013 Jan;145(1):90-6. doi: 10.1016/j.jtcvs.2012.04.022. Epub 2012 Aug 19. PMID 22910197
- BACKGROUNDSarkaria IS, Rizk NP, Finley DJ, Bains MS, Adusumilli PS, Huang J, Rusch VW. Combined thoracoscopic and laparoscopic robotic-assisted minimally invasive esophagectomy using a four-arm platform: experience, technique and cautions during early procedure development. Eur J Cardiothorac Surg. 2013 May;43(5):e107-15. doi: 10.1093/ejcts/ezt013. Epub 2013 Jan 30. PMID 23371971