Self-expandable Metal Stent (SEMS) Endoscopic Placement for Malignant Colonic Obstruction Therapy

NCT05643989 | Unknown DMC

• 1 other identifier: 34-20
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Compare the effectiveness of Self-expandable metal stent (SEMS) and diverting stoma formation for the bowel preparation as a bridge to surgical treatment of patients with MCO.

Conditions

Neoplasms,Colorectal

Outcome Measures

Primary Outcomes (1)

• Bowel preparation (absence of feaces) according to Boston Bowel Preparation Scale

  Evaluated via colonoscopy in colon and rectum distal to the tumour. Total score of bowel preparation measured from 0 to 9. The maximum BBPS score for a perfectly clean colon without any residual liquid is 9 and the minimum BBPS score for an unprepared colon is 0. This is evaluated by the endoscopist

  on the 3rd day after obstruction treatment (SEMS or stoma formation)

Secondary Outcomes (11)

• Intraoperative complications rate during stoma formation or stent placement

  1 day (the day of procedure)

• Early postoperative complications rate after stoma formation or stent placement

  up to 7 days after procedure

• Length of hospital stay after stoma formation or stent placement

  30 days after procedure

• Quality of life before and after stoma formation or stent placement

  -1 day (before procedure), 3rd and 7th day after procedure

• Operation time of resectional surgery

  1 day (the day of tumor resection surgery )

Study Arms (2)

Self-expandable metal stent (SEMS) endoscopic placement.

ACTIVE COMPARATOR

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.

Procedure: Endoscopic self-expandable metal stent placement

Stoma formation.

PLACEBO COMPARATOR

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.

Procedure: Stoma formation

Interventions

Stoma formation PROCEDURE

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.

Stoma formation.

Endoscopic self-expandable metal stent placement PROCEDURE

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.

Self-expandable metal stent (SEMS) endoscopic placement.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are 18 years old or older
• Stage I-IV according to TNM classification
• Patients with malignant colonic obstruction
• Overall health status according to ASA classification: I-III
• Overall health status according to Charlson comorbidity index ≤ 8 points
• Signed informed consent with agreement to attend all study visits
• The patient is not pregnant

You may not qualify if:

• Inflammatory bowel disease
• Acute purulent process in the abdominal cavity
• The patient wants to withdraw from the clinical trial
• Loss to follow-up

Sponsors & Collaborators

• Russian Society of Colorectal Surgeons: lead

Study Sites (1)

Clinic of colorectal and minimally invasive surgery University Hospital n2, Clinical Center Sechenov First Moscow State Medical University

Moscow, Russia

RECRUITING

Related Publications (10)

• 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.

  PMID: 29786848 BACKGROUND

• 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.

  PMID: 21296855 BACKGROUND

• 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.

  PMID: 17687610 BACKGROUND

• 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.

  PMID: 20140833 BACKGROUND

• 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.

  PMID: 24114608 BACKGROUND

• 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.

  PMID: 26811630 BACKGROUND

• 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.

  PMID: 29470746 BACKGROUND

• 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.

  PMID: 24393894 BACKGROUND

• 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.

  PMID: 25294532 BACKGROUND

• 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.

  PMID: 23700570 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Petr Tsarkov, Prof

  Russian Society of Colorectal Surgeons

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irina Gorovaia, MD

CONTACT

+79175998459; rudenko@kkmx.com

Inna Tulina, MD

CONTACT

+79264086672; tulina@kkmx.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: December 9, 2022
• Study Start: November 1, 2019
• Primary Completion: February 1, 2023
• Study Completion: May 11, 2023
• Last Updated: December 9, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)