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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neoplasms,Colorectal
• Intervention / Treatment: Procedure: Endoscopic self-expandable metal stent placement; Procedure: Stoma formation

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 Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Irina Gorovaia, MD; Phone Number: +79175998459; Email: rudenko@kkmx.com

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Recruiting
    • Clinic of colorectal and minimally invasive surgery University Hospital n2, Clinical Center Sechenov First Moscow State Medical University
    • Contact: Gorovaia Irina; Phone Number: 007-917-599-84-59; Email: rudenko@kkmx.ru
    • Contact: Tsarkov Petr, professor; Phone Number: 007-499-110-32-22; Email: tsarkov@kkmx.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Placebo Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Russian Society of Colorectal Surgeons

Publications and helpful links

General Publications

• 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. Erratum In: CA Cancer J Clin. 2011 Mar-Apr;61(2):134.
• 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.
• 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.
• 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. Review.
• 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. Review.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): May 11, 2023

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Estimate): December 9, 2022

Study Record Updates

• Last Update Posted (Estimate): December 9, 2022
• Last Update Submitted That Met QC Criteria: December 1, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 34-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No