Obsidian Glue in a Stapled Esophagogastric Connection After Esophagectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 interventional study will evaluate the safety and potential to reduce anastomotic leaks after Ivor Lewis esophagectomy with a circular stapled intrathoracic esophagogastric anastomosis. Ninety patients aged 18 to 75 will be enrolled over about three years at University Hospital Ghent. Obsidian® is applied at the anastomosis during surgery, and patients will be followed for one year to monitor leak rates and other safety outcomes. The primary outcome is the incidence of anastomotic leak within 30 days, classified by ECCG categories I-III. Eligible participants must have distal to Siewert II esophageal cancer and be planned for minimally invasive surgery, with several preoperative and intraoperative exclusion criteria to ensure safety. Lead sponsorship is from University Hospital Ghent with collaboration from Vivostat.

Why it matters

Who can join: the full rules

1. Inclusion criteria Preoperatively

   * Subjects ≥ 18 years and ≤ 75 years who are willing to participate and provide written informed consent prior to any study-related procedures.
   * Subjects with esophageal carcinoma (distal until Siewert II) scheduled for elective minimally invasive Ivor Lewis esophagectomy (cT1-4a,N0-3,M0).

   Intra-operatively

   \- Intrathoracic circular stapled esophagogastric anastomosis
2. Exclusion criteria preoperatively

   * Female patients who are pregnant or nursing
   * Participation in another study involving investigational drugs or devices.
   * Use of Avastin within 30 days prior to surgery
   * ASA IV (patient with severe systemic disease that is a constant threat to life)
   * Patients with other malignancies
   * Patients with previous esophageal or gastric surgery
   * Known hypersensitivity to batroxobin and tranexamic acid.
   * HB level \< 8 g/dL
   * Patients on medicine containing acetylsalicylic acid not able to stop using the medicine for medical reasons minimum 3 days before taking the blood sampling.
   * Patients on clopidogrel not able to stop clopidogrel for medical reasons 7 days before blood sampling
   * Patients on other platelet aggregation inhibitor therapies not able to stop using the platelet aggregation inhibitor therapies for 3 days before taking the blood sample.

Intra-operatively

* Intra-operative findings that may preclude conduct of the study procedures, such as pleural metastasis, tumor invasion in other organs, …
* Anastomosis preformed differently than the standard of care
* Excessive bleeding (\>500 ml) prior to anastomosis

Where it's running

• University Hospital Ghent
  Ghent, East-Flanders, Belgium Recruiting
• University Hospital Ghent
  Ghent, East-Flanders, Belgium Not yet recruiting

Study contacts

• Principal investigator: Piet Pattyn — UZ Gent
• Study coordinator: Hanne Vanommeslaeghe
• Email: hanne.vanommeslaeghe@uzgent.be
• Phone: +3293325945

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.