Clinical trial NCT05293054: Healing of Rectal Anastomosis Sealed With a Concentrate Derived From the Patient's Blood, After Rectal Cancer Surgery
Official title: Obsidian in Anastomotic Healing After Rectal Cancer Resection: A Prospective Clinical Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anastomotic Leak Rectum
Rectal Cancer
Anastomotic Leakage
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
First posted: 2022-03-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with biopsy proven rectal cancer subjected to minimally invasive rectal resection with anastomosis (TME or PME).

Brief summary: Rectal cancer is one of the most frequent cancer diseases, with more than 1500 new cases per year in Denmark. Fortunately, if the tumor is discovered early, surgeons can remove the part of the intestine that is afflicted, and they can often sew the intestine-ends back together, forming what is known as an anastomosis. However, in 10-15% of cases, this anastomosis doesn't heal completely, leading to anastomotic leakage. This is a serious complication, with detrimental effects for the individual patient. Previous measures to avoid this complication, have proven unsuccessful.

Obsidian is a mixture derived from the patients' own blood, that contains components of blood normally responsible for stopping bleeding and kickstarting the healing process. It is already used in other clinical settings and preliminary, yet unpublished, results from a pilot study have shown its promise in decreasing the risk of anastomotic leakage in rectal anastomosis. However, its use has not been examined when performing surgery for rectal cancer with minimally invasive technique, which is today's standard.

The main clinical hypothesis of this feasibility study is that it is possible for colorectal surgeons to apply Obsidian successfully on the anastomotic area with minimal invasive technique, as a supplement during rectal cancer resection with anastomosis.

This study will be conducted at the Department of Surgery, Aarhus University Hospital. 50 patients will be included, who will undergo minimally invasive rectal cancer surgery with an anastomosis. Right after the onset of anaesthesia, 120 ml of blood will be collected from the patient and will be processed, making a 5-6 ml Obsidian concentrate. When the tumor-bearing part of the rectum has been removed, Obsidian will be applied, according to a pre-specified protocol.

If the application is deemed successful (based on predefined assessment criteria) in at least 90% of our included patients, then this study will serve as a stepping stone for a bigger study, the aim of which will be to assess if this method can indeed bring down the rate of anastomotic leakage in such patients.


Eligibility criteria: Inclusion Criteria:

* Primary rectal cancer (adenocarcinoma) with the lower boarder within 15 cm from the anal verge assessed by rigid proctoscopy
* Clinical UICC stage I-III at time of rectal cancer diagnosis
* Deemed suitable for intended curative rectal cancer resection at MDT either by total mesorectal excision (TME) or partial mesorectal excision (PME)
* Scheduled for elective, minimal invasive surgery
* ECOG performance status 0-2
* Age at least 18 years
* Written and orally informed consent

Exclusion Criteria:

* Distant metastatic disease
* Locally advanced rectal cancer requiring extended resection
* Open surgery
* Benign lesions of the rectum
* Inflammatory bowel disease
* Another malignant disease within previous 2 years
* Inability and unwillingness to give informed consent
* Pregnant (positive pregnancy test) or breast feeding women

Primary outcomes:
measure: The rate of successful use and application of Obsidian as a supplemental procedure in the creation of rectal anastomosis with minimal invasive technique
timeFrame: This outcome is measured during the intervention.
Secondary outcomes:
measure: Time spent for creating a rectal anastomosis with application of Obsidian
timeFrame: This outcome is measured during the intervention.
measure: The surgeon's self-assessment of the user-friendliness of using Obsidian
timeFrame: This outcome is measured immediately after the intervention.
measure: Anastomotic leak rate
timeFrame: Measured within 30 days after surgery
measure: Length of hospital stay
timeFrame: From, and including, day of surgery to, and including, day of discharge, or up to 90 days after surgery.
measure: Re-hospitalization within 30 days after surgery
timeFrame: Measured within 30 days after surgery
measure: Morbidity within 30 days after surgery graded ≥3 severity according to the Clavien-Dindo classification
timeFrame: Measured within 30 days after surgery
measure: 2-year mortality
timeFrame: Within 2 years after surgery
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Surgery, Aarhus University Hospital
state: Central Denmark Region
Study officials:
affiliation: Department of Surgery, Aarhus University Hospital
name: Lene H Iversen, DMSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rahbari NN, Weitz J, Hohenberger W, Heald RJ, Moran B, Ulrich A, Holm T, Wong WD, Tiret E, Moriya Y, Laurberg S, den Dulk M, van de Velde C, Buchler MW. Definition and grading of anastomotic leakage following anterior resection of the rectum: a proposal by the International Study Group of Rectal Cancer. Surgery. 2010 Mar;147(3):339-51. doi: 10.1016/j.surg.2009.10.012. Epub 2009 Dec 11.