History of Changes for Study: NCT05713955

OBSiDiAN in a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy

Latest version (submitted January 9, 2024) on ClinicalTrials.gov

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Study Record Versions

Version	Submitted Date	Changes
1	February 1, 2023	None (earliest Version on record)
2	May 25, 2023	Study Status, Outcome Measures, Study Design, Eligibility, Arms and Interventions and Study Description
3	July 31, 2023	Study Status
4	November 13, 2023	Study Status
5	January 9, 2024	Recruitment Status, Study Status, Study Design and Contacts/Locations

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Study NCT05713955
Submitted Date: February 1, 2023 (v1)

Study Identification


Unique Protocol ID:	BC-09974
Brief Title:	OBSiDiAN in a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy
Official Title:	Evaluation of Effectiveness and Safety of Autologous BioMatrix OBSiDiAN to Enhance a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy in a Multicentre Randomized Controlled Trial.
Secondary IDs:

Study Status


Record Verification:	February 2023
Overall Status:	Not yet recruiting
Study Start:	March 1, 2023
Primary Completion:	January 1, 2027 [Anticipated]
Study Completion:	January 1, 2027 [Anticipated]

First Submitted:	November 8, 2021
First Submitted that Met QC Criteria:	February 1, 2023
First Posted:	February 6, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	February 1, 2023
Last Update Posted:	February 6, 2023 [Actual]

Study Description

Brief Summary:

Multicentre randomized controlled trial to evaluate the effectiveness of an autologous BioMatrix on a circular stapled esophagogastric anastomosis after Ivor Lewis esophagectomy.

Detailed Description:

STUDY PRODUCT Autologous BioMatrix: Obsidian (medical device class III)

STUDY POPULATION Subjects ≥ 18 years and ≤ 75 years of age scheduled for elective Ivor Lewis esophagectomy for oesophageal cancer with a circular stapled intrathoracic esophagogastric anastomosis.

SAMPLE SIZE A total of 250 patients will be included in the study. 125 patients in each study arm.

ENROLEMENT PERIOD Based on an annual number of 70-80 esophagectomies in this centre, University Hospital Ghent, with inclusion of patients in a German, three or two Austrian and a Dutch centre, we predict an enrolment period of 2 years.

PRIMARY ENDPOINT Absence of anastomotic leak within 30 days post operatively. Anastomotic leak is defined according to the Esophagectomy Complications Consensus Group (ECCG) type III.

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Not Applicable
Interventional Study Model:	Parallel Assignment
	Design : An international, multicentre randomized controlled trial evaluating the effectiveness and safety of autologous BioMatrix OBSiDiAN in reducing the incidence of anastomotic leaks following Ivor Lewis esophagectomy for oesophageal carcinoma. Randomization : Eligible patients will randomized in a 1:1 allocation to either the autologous BioMatrix OBSiDiAN group (study group) or the standard of care group (control group). Procedure: For both the control group and intervention group: A standard laparoscopic or open Ivor Lewis esophagectomy with an intrathoracic end-to-side stapled esophagogastric anastomosis. For the intervention group: After the abdominal fase and randomisation, a 120 ml blood sample will be drawn from the patient and put in the Vivostat® processor unit to make Obsidian. At the time of the anastomosis Obsidian will be applied between and around the esophagogastric anastomosis
Number of Arms:	2
Masking:	Single (Participant)
Allocation:	Randomized
Enrollment:	250 [Anticipated]

Arms and Interventions

Arms

Assigned Interventions

Active Comparator: study group

For the study group, a unit of autologous BioMatrix OBSiDiAN will be produced. Blood sample (120ml) will be taken after randomization at the ending of the abdominal phase of the surgery. The surgeon will create an esophagogastric anastomosis, after ruling out tension or torsion. Around 1-2ml of autologous BioMatrix OBSiDiAN will be applied on the distal/or proximal resection stump before the stapled anastomose will be created. After firing the standard circular device and creation of a functional anastomosis, a further 2.5-3ml OBSiDiAN must be applied circumferentially on the outside on the anastomosis. Once application is completed, a 30 seconds waiting period is required before putting the esophagus back into the surgical field (study specific). A methylene blue leakage test is performed (standard of care). If there is a leak, the anastomosis will be corrected or the completed procedure has to be done again.

Device: Obsidian

To create OBSiDiAN BioMatrix, 120 ml of the the patient's blood is added to the processing unit. The Vivostat® processor unit heats, separates, centrifugates to get the plasma. Batroxobin is added. After again processing, the result is an OBSiDian syringe filled with BioMatrix Obsidian®ASG. This will be applied on the anastomosis

No Intervention: standard group

The surgeon will create an esophagogastric anastomosis, after ruling out tension or torsion. A methylene blue leakage test is performed (standard of care). If there is a leak, the anastomosis will be corrected.

Outcome Measures


Primary Outcome Measures:
1.	Anastomotic leak [ Time Frame: Absence of anastomotic leak within 30 days post operatively ] Anastomotic leak defined according to the ECCG guidelines11 type III: localized defect requiring surgical therapy
Secondary Outcome Measures:
1.	mortality [ Time Frame: from surgery until 30 days post operative ] in hospital mortality
2.	sepsis [ Time Frame: from surgery until 30 day post operative ] in hospital sepsis
3.	pneumonia [ Time Frame: from surgery until 30 day post operative ] in hospital pneumonia
4.	late anastomotic leakage [ Time Frame: from surgery until 90 days post operative ] late anastomotic leakage
5.	stricture [ Time Frame: from surgery until 1 year post operative ] stricture of the esophagogastric anastomosis
6.	inflammation [ Time Frame: from date of randomisation to postoperative day 5 ] post operative inflammation (WBC)
7.	inflammation [ Time Frame: from date of randomisation to postoperative day 5 ] post operative inflammation (CRP)
8.	ICU stay [ Time Frame: from surgery until discharge or until the date of death from any cause, whichever came first, assessed up to 3 months ] length of ICU stay
9.	hospital stay [ Time Frame: from surgery until discharge or until the date of death from any cause, whichever came first, assessed up to 3 months ] total hospital stay
10.	thoracic drainage volume [ Time Frame: from surgery until removal of thoracic drain within the first week postoperative ] Volume of thoracic drain
11.	thoracic drainage duration [ Time Frame: from surgery until removal of thoracic drain within the first week postoperative ] duration of thoracic drain

Eligibility


Minimum Age:	18 Years
Maximum Age:	75 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	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 oesophageal carcinoma scheduled for elective minimally invasive or open Ivor Lewis esophagectomy Intra-operatively intrathoracic circular stapled esophagogastric anastomosis 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 (American Society of Anesthesiologists physical status classification system: patient with severe systemic disease that is a constant threat to life) Patients with other malignancies Patients with previous oesophageal or gastric surgery Known hypersensitivity to batroxobin and tranexamic acid. Hemoglobin level < 8 g/dL 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

Contacts/Locations


Central Contact Person:	Hanne Vanommeslaeghe Telephone: +3293325945 Email: hanne.vanommeslaeghe@uzgent.be
Study Officials:	Piet Pattyn Principal Investigator UZ Gent
Locations:

References


Citations:	[Study Results] Plat VD, Bootsma BT, van der Wielen N, van der Peet DL, Daams F. Autologous Activated Fibrin Sealant for the Esophageal Anastomosis: A Feasibility Study. J Surg Res. 2019 Feb;234:49-53. doi: 10.1016/j.jss.2018.08.049. Epub 2018 Sep 27. PubMed 30527497
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