Prospective Randomized Comparative Study of the Treatment of Multisegmental Fibrostenosing Crohn's Disease. (SUREST)
Primary Purpose
Crohn Disease, Stricture; Bowel
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Surgical resection
Endoscopic stricturotomy
Strictureplasty
Sponsored by
About this trial
This is an interventional treatment trial for Crohn Disease
Eligibility Criteria
Inclusion Criteria:
- Subjects had been diagnosed with CD for at least 3 months prior to screening, and the diagnosis of CD had clinical findings and endoscopic, imaging evidence, and was supported by histopathology reports
- Subject is in remission from CD (CDAI score < 150)
- Subjects had clinical findings of multiple fibrotic strictures of the bowel with obstruction (abdominal pain with distension, decreased stool frequency and / or symptoms of nausea and vomiting) and imaging evidence (MRE and bowel color ultrasound suggested intestinal fibrosis with greater than 50% reduction in diameter and greater than 20% thickening of the bowel wall with dilation of the proximal bowel), and endoscopic evidence (endoscopy was unable to pass)
- Subjects had ≥ 2 small bowel strictures from duodenum to rectum and ≥ 20 cm maximum distance between coloanal and caudal strictures
- Study process prior to initiation, the subject or subject's legal representative (if applicable) signed and dated a written informed consent form or any required documentation of privacy authorization
- Female subjects who remained sexually and of childbearing potential with an ungerminated male partner, consented to adequate routine contraception throughout the study period starting with signing informed consent
Exclusion Criteria:
- At the initial screening visit, subject presented with enterocutaneous fistula, abdominal abscess, evidence of gastrointestinal bleeding
- Subjects were in active CD (CDAI score ≥ 150)
- The subject had inflammatory activity in the stenotic bowel (as judged by a combination of blood inflammatory indices, endoscopy, ultrasound and imaging)
- Presence of ileostomy, colostomy
- Subjects had a history or evidence of adenomatous colonic polyps that had not been resected or had a history or evidence of dysplasia of the colonic mucosa, including low - or high-grade dysplasia, and an undiagnosed type of dysplasia
- Subjects had suspected or confirmed ulcerative colitis, undiagnosed types of colitis, ischemic colitis, radiation enteritis, colitis associated diverticular disease, or microscopic colitis
- Subjects had evidence of active infection during the screening period
- Subject has active tuberculosis: chest X-ray performed within 3 months prior to week 0 results suggestive of suspected tuberculosis
- Subjects with any defined inborn or acquired immunodeficiency (e.g., common various immunodeficiencies, human immunodeficiency virus [HIV] infection, organ transplantation)
- Subjects had a clinically significant infection (e.g., pneumonia, pyelonephritis) or an ongoing chronic infection within 30 days prior to screening
- The subject suffered from any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immune, endocrine / metabolic or other medical condition that, in the opinion of the investigator, would interfere with the outcome of the study or jeopardize the safety of the subject
- The subject's medical history included malignancy
- Subjects had abnormal laboratory results for any of the following during screening: hemoglobin < 5 g / dl; white blood cell (WBC) count < 3 × 10E9 / L; platelet count < 100 × 10E9 / L or > 1200 × 10E9 / L; alanine transaminase (ALT) or aspartate transaminase (AST) > 3 × upper limit of normal (ULN), and serum creatinine > 2 × ULN.
- Subjects were unable to attend all study visits or comply with study flow plans female subjects were pregnant prior to study enrollment, during study enrollment, or plan to donate eggs during these time periods
- Subjects were forced to consent to participate in the study
- Investigators considered the subject unsuitable for endoscopic or surgical treatment
Sites / Locations
- The Sixth Affiliated Hospital, Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SRES group
SRS group
Arm Description
Surgical resection plus endoscopic stricturotomy for multiple fibrous stenosis
Surgical resection plus strictureplasty for multiple fibrous stenosis
Outcomes
Primary Outcome Measures
Intervention-free survival
Percentage of patients who do not receive surgical or endoscopic intervention for obstruction recurrence
Secondary Outcome Measures
Surgery-free survival
Percentage of patients who do not receive surgical intervention for obstruction recurrence
Obstructive score reduction
Obstructive score reduction compared to baseline
CDAI score reduction
CDAI score reduction compared to baseline
IBDQ score reduction
IBDQ score reduction compared to baseline
Adverse event rate
Percentage of adverse events
Total cost for intervention
Total cost for intervention
Full Information
NCT ID
NCT04865484
First Posted
April 27, 2021
Last Updated
April 28, 2021
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT04865484
Brief Title
Prospective Randomized Comparative Study of the Treatment of Multisegmental Fibrostenosing Crohn's Disease.
Acronym
SUREST
Official Title
Prospective Randomized Comparative Study of the Treatment of Multisegmental Fibrostenosing Crohn's Disease. Surgical Resection Plus Endoscopic Stricturotomy Versus Surgical Resection Plus Strictureplasty
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 12, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Stenosis is one of the most frequent complications in patients with Crohn's disease (CD). In particular, CD patients with multi segmental intestinal strictures are often faced with short bowel syndrome after repeated or extensive surgical resection.
Strictureplasty conserves bowel and minimizes the risk of developing short-bowel syndrome in the short-term and, probably, long-term. Strictureplasty has become an established surgical option in the management of obstructive Crohn's disease, especially for multiple short fibrous strictures. It is particularly suitable for patients at risk for short-bowel syndrome.
Endoscopic management shows good efficacy and safety in the treatment of strictures in CD patients. The ECCO guideline recommended that endoscopic balloon dilatation is suitable to treat short [<5 cm] strictures of the terminal ileum in CD. Recently, Lan et al. reported that endoscopic stricturotomy appeared to be more effective in treating CD patients with anastomotic stricture than endoscopic balloon dilatation.
However, there is no scientific evidence for determining the most appropriate treatment for multiple fibrosis stenosis. We designed a prospective randomized comparative study of the treatment of multisegmental fibrostenosing Crohn's disease (surgical resection plus endoscopic stricturotomy versus surgical resection plus strictureplasty).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Stricture; Bowel
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SRES group
Arm Type
Experimental
Arm Description
Surgical resection plus endoscopic stricturotomy for multiple fibrous stenosis
Arm Title
SRS group
Arm Type
Active Comparator
Arm Description
Surgical resection plus strictureplasty for multiple fibrous stenosis
Intervention Type
Procedure
Intervention Name(s)
Surgical resection
Intervention Description
Surgical resection of fibrostenotic area (>4cm)
Intervention Type
Procedure
Intervention Name(s)
Endoscopic stricturotomy
Intervention Description
Endoscopic stricturotomy of fibrostenotic area (≤4cm)
Intervention Type
Procedure
Intervention Name(s)
Strictureplasty
Intervention Description
Strictureplasty of fibrostenotic area (≤4cm)
Primary Outcome Measure Information:
Title
Intervention-free survival
Description
Percentage of patients who do not receive surgical or endoscopic intervention for obstruction recurrence
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Surgery-free survival
Description
Percentage of patients who do not receive surgical intervention for obstruction recurrence
Time Frame
52 weeks
Title
Obstructive score reduction
Description
Obstructive score reduction compared to baseline
Time Frame
Week 4、12、20、28、36、44、52
Title
CDAI score reduction
Description
CDAI score reduction compared to baseline
Time Frame
Week 4、12、20、28、36、44、52
Title
IBDQ score reduction
Description
IBDQ score reduction compared to baseline
Time Frame
Week 4、12、20、28、36、44、52
Title
Adverse event rate
Description
Percentage of adverse events
Time Frame
52 weeks
Title
Total cost for intervention
Description
Total cost for intervention
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects had been diagnosed with CD for at least 3 months prior to screening, and the diagnosis of CD had clinical findings and endoscopic, imaging evidence, and was supported by histopathology reports
Subject is in remission from CD (CDAI score < 150)
Subjects had clinical findings of multiple fibrotic strictures of the bowel with obstruction (abdominal pain with distension, decreased stool frequency and / or symptoms of nausea and vomiting) and imaging evidence (MRE and bowel color ultrasound suggested intestinal fibrosis with greater than 50% reduction in diameter and greater than 20% thickening of the bowel wall with dilation of the proximal bowel), and endoscopic evidence (endoscopy was unable to pass)
Subjects had ≥ 2 small bowel strictures from duodenum to rectum and ≥ 20 cm maximum distance between coloanal and caudal strictures
Study process prior to initiation, the subject or subject's legal representative (if applicable) signed and dated a written informed consent form or any required documentation of privacy authorization
Female subjects who remained sexually and of childbearing potential with an ungerminated male partner, consented to adequate routine contraception throughout the study period starting with signing informed consent
Exclusion Criteria:
At the initial screening visit, subject presented with enterocutaneous fistula, abdominal abscess, evidence of gastrointestinal bleeding
Subjects were in active CD (CDAI score ≥ 150)
The subject had inflammatory activity in the stenotic bowel (as judged by a combination of blood inflammatory indices, endoscopy, ultrasound and imaging)
Presence of ileostomy, colostomy
Subjects had a history or evidence of adenomatous colonic polyps that had not been resected or had a history or evidence of dysplasia of the colonic mucosa, including low - or high-grade dysplasia, and an undiagnosed type of dysplasia
Subjects had suspected or confirmed ulcerative colitis, undiagnosed types of colitis, ischemic colitis, radiation enteritis, colitis associated diverticular disease, or microscopic colitis
Subjects had evidence of active infection during the screening period
Subject has active tuberculosis: chest X-ray performed within 3 months prior to week 0 results suggestive of suspected tuberculosis
Subjects with any defined inborn or acquired immunodeficiency (e.g., common various immunodeficiencies, human immunodeficiency virus [HIV] infection, organ transplantation)
Subjects had a clinically significant infection (e.g., pneumonia, pyelonephritis) or an ongoing chronic infection within 30 days prior to screening
The subject suffered from any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immune, endocrine / metabolic or other medical condition that, in the opinion of the investigator, would interfere with the outcome of the study or jeopardize the safety of the subject
The subject's medical history included malignancy
Subjects had abnormal laboratory results for any of the following during screening: hemoglobin < 5 g / dl; white blood cell (WBC) count < 3 × 10E9 / L; platelet count < 100 × 10E9 / L or > 1200 × 10E9 / L; alanine transaminase (ALT) or aspartate transaminase (AST) > 3 × upper limit of normal (ULN), and serum creatinine > 2 × ULN.
Subjects were unable to attend all study visits or comply with study flow plans female subjects were pregnant prior to study enrollment, during study enrollment, or plan to donate eggs during these time periods
Subjects were forced to consent to participate in the study
Investigators considered the subject unsuitable for endoscopic or surgical treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qin Guo, MD
Phone
+86-20-38663423
Email
guoq83@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Hongsheng Yang, MD
Phone
+86-20-38663423
Email
hensonyang@foxmail.com
Facility Information:
Facility Name
The Sixth Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510065
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongsheng Yang, MD
Phone
+86-20-38663423
Email
hensonyang@foxmail.com
First Name & Middle Initial & Last Name & Degree
Qin Guo, MD
First Name & Middle Initial & Last Name & Degree
Jia Ke, MD
12. IPD Sharing Statement
Learn more about this trial
Prospective Randomized Comparative Study of the Treatment of Multisegmental Fibrostenosing Crohn's Disease.
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