NCT05643989

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

Randomized Non-inferiority Single-center Prospective Trial of Malignant Colonic Obstruction Therapy With Self-expandable Metal Stent (SEMS) Endoscopic Placement or Stoma Formation.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Russian Society of Colorectal Surgeons · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Surgical treatment of MCO is associated with high mortality and frequent development of postoperative complications. Stoma formation is the traditional method of urgent treatment of MCO. Currently there are more than 150 methods of colorectal stomas formation, but all of themare associated with a high risk of complications (10-20%), inclusively both early and late postoperative period. It results in longerhospital stay and requires additional financial expenses, also reoperations can be fatal for patients. 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

• Neoplasms,Colorectal

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2019-11-01
• Primary completion: 2023-02-01
• Completion: 2023-05-11
• First posted: 2022-12-09
• Last updated: 2022-12-09

Locations

1 site across 1 country: Russia