Self-expandable Metal Stent (SEMS) Endoscopic Placement for Malignant Colonic Obstruction Therapy
NCT ID: NCT05643989
Last Updated: 2022-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
56 participants
INTERVENTIONAL
2019-11-01
2023-05-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Analysis of recent publications devoted to the treatment of MCO shows increasing implemented of new strategies of patents management, such as "fast track surgery", or "fast track recovery strategy" in clinical practice. Minimally invasive endoscopic procedures as a first stage of MCO treatment leads to transformation of previously performed multi-stage surgical interventions into one - stage.
Development of up-to-date endoscopic science and technology provides a wide usage ofself-expandable metal stent (SEMS) in clinical practice. This strategy helps to avoid stoma formation or emergency surgery, becoming a "bridge" to a radical surgery.
There are currently no studies directly comparing discharge stoma with endoscopic self-expandable metal stenting in preparation for colorectal cancer radical surgery.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Self-expandable metal stent (SEMS) endoscopic placement.
Anesthesia will include only propofol injection. A covered or partially covered metal self- expanding stent is placed in the area of tumor stenosis by the conductor, symmetrically in relation to the area of tumor stenosis.
Endoscopic self-expandable metal stent placement
The colonoscope is passed to the distal edge of the tumor and a biopsy of the tumor is performed (if the tumor has not previously been verified). Through the tumor stenosis radioscopically guided metal conductor with atraumatic distal end installs in the proximal colon. A covered or partially covered metal self- expanding stent is placed in the area of tumor stenosis by the conductor, symmetrically in relation to the area of tumor stenosis. Radioscopically and endoscopically guided disclosure of a SEMS is performed immediately after which there is an abundant discharge of gases and intestinal contents. Upon completion of the procedure, the patient is transferred to the patient's room. The next day, a control X-ray of the abdomen is taken.
Stoma formation.
Anesthetic care will include general endotracheal anesthesia with positioning of nasogastric tube and bladder catheterization. The diverting stoma formation will be proceed in 10 sm proximally to tumor.
Stoma formation
Trocar placement: the optical trocar (10 mm) will be inserted just near umbilicus . An abdominal revision is performed to determine the location of the tumor. Colon in 10 sm proximally to tumor is prepared for the discharge stoma formation. In the corresponding location on the anterior abdominal wall is formed incision of skin and subcutaneous tissue to the aponeurosis, the cut length is 2.5 sm. After that, aponeurosis crucial incision is performed. The previously prepared colon is brought out to the anterior abdominal wall with the help of a grasper. Discharge stoma is attached to a holding device; colon is fixed by the interrupted sutures (Polysorb 3-0). In the operating room, the stoma is opened, the intestinal patency is checked in both directions, and hemostasis is revealed. With the help of optics, the presence of intestinal tension is checked; if necessary, the colon is additionally mobilized.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Stoma formation
Trocar placement: the optical trocar (10 mm) will be inserted just near umbilicus . An abdominal revision is performed to determine the location of the tumor. Colon in 10 sm proximally to tumor is prepared for the discharge stoma formation. In the corresponding location on the anterior abdominal wall is formed incision of skin and subcutaneous tissue to the aponeurosis, the cut length is 2.5 sm. After that, aponeurosis crucial incision is performed. The previously prepared colon is brought out to the anterior abdominal wall with the help of a grasper. Discharge stoma is attached to a holding device; colon is fixed by the interrupted sutures (Polysorb 3-0). In the operating room, the stoma is opened, the intestinal patency is checked in both directions, and hemostasis is revealed. With the help of optics, the presence of intestinal tension is checked; if necessary, the colon is additionally mobilized.
Endoscopic self-expandable metal stent placement
The colonoscope is passed to the distal edge of the tumor and a biopsy of the tumor is performed (if the tumor has not previously been verified). Through the tumor stenosis radioscopically guided metal conductor with atraumatic distal end installs in the proximal colon. A covered or partially covered metal self- expanding stent is placed in the area of tumor stenosis by the conductor, symmetrically in relation to the area of tumor stenosis. Radioscopically and endoscopically guided disclosure of a SEMS is performed immediately after which there is an abundant discharge of gases and intestinal contents. Upon completion of the procedure, the patient is transferred to the patient's room. The next day, a control X-ray of the abdomen is taken.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Stage I-IV according to TNM classification
3. Patients with malignant colonic obstruction
4. Overall health status according to ASA classification: I-III
5. Overall health status according to Charlson comorbidity index ≤ 8 points
6. Signed informed consent with agreement to attend all study visits
7. The patient is not pregnant
Exclusion Criteria
2. Acute purulent process in the abdominal cavity
3. The patient wants to withdraw from the clinical trial
4. Loss to follow-up
18 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Russian Society of Colorectal Surgeons
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Petr Tsarkov, Prof
Role: PRINCIPAL_INVESTIGATOR
Russian Society of Colorectal Surgeons
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinic of colorectal and minimally invasive surgery University Hospital n2, Clinical Center Sechenov First Moscow State Medical University
Moscow, , Russia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Gorovaia Irina
Role: primary
Tsarkov Petr, professor
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
Cronin KA, Lake AJ, Scott S, Sherman RL, Noone AM, Howlader N, Henley SJ, Anderson RN, Firth AU, Ma J, Kohler BA, Jemal A. Annual Report to the Nation on the Status of Cancer, part I: National cancer statistics. Cancer. 2018 Jul 1;124(13):2785-2800. doi: 10.1002/cncr.31551. Epub 2018 May 22.
Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
Cheynel N, Cortet M, Lepage C, Benoit L, Faivre J, Bouvier AM. Trends in frequency and management of obstructing colorectal cancers in a well-defined population. Dis Colon Rectum. 2007 Oct;50(10):1568-75. doi: 10.1007/s10350-007-9007-4.
Baron TH. Colonic stenting: a palliative measure only or a bridge to surgery? Endoscopy. 2010 Feb;42(2):163-8. doi: 10.1055/s-0029-1243881. Epub 2010 Feb 5.
Larkin JO, Moriarity AR, Cooke F, McCormick PH, Mehigan BJ. Self-expanding metal stent insertion by colorectal surgeons in the management of obstructing colorectal cancers: a 6-year experience. Tech Coloproctol. 2014 May;18(5):453-8. doi: 10.1007/s10151-013-1073-0. Epub 2013 Oct 10.
Kim EJ, Kim YJ. Stents for colorectal obstruction: Past, present, and future. World J Gastroenterol. 2016 Jan 14;22(2):842-52. doi: 10.3748/wjg.v22.i2.842.
Maleckis K, Anttila E, Aylward P, Poulson W, Desyatova A, MacTaggart J, Kamenskiy A. Nitinol Stents in the Femoropopliteal Artery: A Mechanical Perspective on Material, Design, and Performance. Ann Biomed Eng. 2018 May;46(5):684-704. doi: 10.1007/s10439-018-1990-1. Epub 2018 Feb 22.
Nakata K, Fukunaga M, Ebihara T, Kato F, Amano K, Babaya A, Matsushita A, Furukawa H, Matsushima Y, Matsumoto H, Fujihara S, Kawabata R, Usui A, Yamamoto T, Oda K, Kawase T, Kimura Y, Nakata Y, Ohzato H. [A study of laparoscopic stoma creation for patients with malignant bowel obstruction]. Gan To Kagaku Ryoho. 2013 Nov;40(12):1702-4. Japanese.
van den Berg MW, Ledeboer M, Dijkgraaf MG, Fockens P, ter Borg F, van Hooft JE. Long-term results of palliative stent placement for acute malignant colonic obstruction. Surg Endosc. 2015 Jun;29(6):1580-5. doi: 10.1007/s00464-014-3845-7. Epub 2014 Oct 8.
Kim YW, Kim IY. The Role of Surgery for Asymptomatic Primary Tumors in Unresectable Stage IV Colorectal Cancer. Ann Coloproctol. 2013 Apr;29(2):44-54. doi: 10.3393/ac.2013.29.2.44. Epub 2013 Apr 30.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
34-20
Identifier Type: -
Identifier Source: org_study_id