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

Not Applicable

Recruiting

• Conditions: Neoplasms,Colorectal
• Interventions: Procedure: Endoscopic self-expandable metal stent placement; Procedure: Stoma formation

• Registration Number: NCT05643989
• Lead Sponsor: Russian Society of Colorectal Surgeons

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.

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.

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2022-06-10
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-01
• Last Update Submitted: 2022-12-01
• Study First Posted: 2022-12-09
• Last Update Posted: 2022-12-09
• Primary Completion: 2023-02-01
• Study Completion: 2023-05-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

1. Patients are 18 years old or older
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

1. Inflammatory bowel disease
2. Acute purulent process in the abdominal cavity
3. The patient wants to withdraw from the clinical trial
4. Loss to follow-up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-expandable metal stent (SEMS) endoscopic placement.	Endoscopic self-expandable metal stent 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.
Stoma formation.	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.

Primary Outcome Measures

Name	Time	Method
Bowel preparation (absence of feaces) according to Boston Bowel Preparation Scale	on the 3rd day after obstruction treatment (SEMS or stoma formation)	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

Secondary Outcome Measures

Name	Time	Method
Intraoperative complications rate during stoma formation or stent placement	1 day (the day of procedure)	The rate of complications during the procedure
Early postoperative complications rate after stoma formation or stent placement	up to 7 days after procedure	The rate of complications after the procedure
Length of hospital stay after stoma formation or stent placement	30 days after procedure	Number of days spent in hospital after procedure
Quality of life before and after stoma formation or stent placement	-1 day (before procedure), 3rd and 7th day after procedure	Measured by patient-reported SF-36 scale before and after procedure
Operation time of resectional surgery	1 day (the day of tumor resection surgery )	The duration of surgical procedure in minutes
Stoma formation rate	1 day (the day of tumor resection surgery )	The percentage of patients who had preventive or definitive stoma during resectional surgery in the SEMS group
Stoma reversal rate	1 day (the day of tumor resection surgery )	The rate of previously formed stoma reversal simultaneously with tumor resection
Early postoperative complications rate after resectional surgery	30 days after resectional surgery	The rate complications after tumor resection surgery
Length of hospital stay after resectional surgery	30 days after resectional surgery	Number of days spent in hospital after tumor resection surgery
Intraoperative complications rate during resectional surgery	1 day (the day of resectional surgery)	The rate of complications during tumor resection surgery
Late complications rate during resectional surgery	31-90 days after tumor resection surgery	The rate of complications after tumor resection surgery

Trial Locations

Locations (1)

Clinic of colorectal and minimally invasive surgery University Hospital n2, Clinical Center Sechenov First Moscow State Medical University; 🇷🇺 Moscow, Russian Federation