Ignite Creation Date:
2024-05-06 @ 8:11 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02682485
Status:
WITHDRAWN
Last Update Posted:
2023-04-26
First Post:
2016-02-08
Brief Title:
Serial Endoscopic Surveillance Direct Topical Antibiotics to Define the Role of Microbes in Anastomotic Healing
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
A Multicenter Phase II Randomized Double-Blinded Placebo-Controlled Clinical Trial of Serial Endoscopic Surveillance SES and Direct Topical Antibiotics DTA to Define the Role of Microbes in Anastomotic Healing
Status:
WITHDRAWN
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SES-DTA
Brief Summary:
Rationale The surgical complication of intestinal anastomotic leak remains a clear and present danger to patients despite advances in surgical technique and ever more powerful antibiotics No surgeon is immune from this complication and leak rates have not changed in decades The consequences of a leak peritonitis sepsis death can be so severe that in the case of rectal cancer diverting ileostomies are routinely performed to divert the fecal stream away from the healing anastomosis We have recently discovered that certain intestinal bacteria with the capacity to express collagenase and cleave MMP9 Matrix metallopeptidase 9 to its active collagen degrading form play a key and causative role in anastomotic leak These bacteria often escape elimination due to the failure of current antibiotic regimens and their delivery methods to remain functionally durable at anastomotic tissue sites
Purpose This phase II clinical trial will track in real time the process of anastomotic healing and its associated microbiome by performing serial endoscopic surveillance SES following rectal cancer resection By capturing anastomotic images and the associated microbial and inflammatory mediators from anastomotic fluids via SES performed at three time points following rectal cancer resection we will correlate healing to microbial composition and inflammatory mediator status Patients will be randomized and at each time point will receive lavage of their anastomosis with either saline or a triple antibiotic solution ciprofloxacin metronidazole neomycin An anastomotic healing score captured during SES will be compared between the two treatment arms and correlated to microbial and inflammatory mediator analyses of fluid samples to determine how intestinal microbes influence the process of anastomotic healing
Purpose This phase II clinical trial will track in real time the process of anastomotic healing and its associated microbiome by performing serial endoscopic surveillance SES following rectal cancer resection By capturing anastomotic images and the associated microbial and inflammatory mediators from anastomotic fluids via SES performed at three time points following rectal cancer resection we will correlate healing to microbial composition and inflammatory mediator status Patients will be randomized and at each time point will receive lavage of their anastomosis with either saline or a triple antibiotic solution ciprofloxacin metronidazole neomycin An anastomotic healing score captured during SES will be compared between the two treatment arms and correlated to microbial and inflammatory mediator analyses of fluid samples to determine how intestinal microbes influence the process of anastomotic healing
Detailed Description:
OBJECTIVES
Perform repeated postoperative endoscopy of anastomotic tissue sites in patients undergoing low anterior resection for rectal cancer with diverting ileostomy
Demonstrate that SES can reliably discriminate those anastomoses that progress along a continuum toward normal healing versus those that heal pathologically when images are evaluated by a jury blinded to treatment
Demonstrate that those anastomoses that are judged to progress pathologically harbor distinct microbial species and predictive inflammatory mediators
Demonstrate that when anastomotic tissues are lavaged with antibiotics directly via endoscopy ciprofloxacin metronidazole neomycin microbial pathogens that escape conventional antibiotics are eliminated and anastomotic healing progresses normally
Determine if the anastomotic healing score microbial analyses andor inflammatory mediator analyses identify or predict symptomatic and clinically relevant anastomotic complications
STUDY This is a randomized multicenter study All patients undergo resection of rectal cancer with a low anterior resection with anastomoses within 10cm of the anal verge and diverting ileostomy Patients will undergo three endoscopies one intra-operative endoscopy POD0 and two post-operative endoscopies POD3-7 POD12-28 POD post-operative day During the SES procedure the anastomosis will be lavaged with saline the fluid will be collected by suction images will be taken and then the anastomosis will be lavaged with either saline or an antibiotic solution composed of metronidazole ciprofloxacin and neomycin Patients clinical courses will be followed through chart review for 6 to 7 months following surgery
PROJECTED ACCRUAL A total of 200 patients approximately 100 per treatment arm will be accrued for this study within 4 years
Perform repeated postoperative endoscopy of anastomotic tissue sites in patients undergoing low anterior resection for rectal cancer with diverting ileostomy
Demonstrate that SES can reliably discriminate those anastomoses that progress along a continuum toward normal healing versus those that heal pathologically when images are evaluated by a jury blinded to treatment
Demonstrate that those anastomoses that are judged to progress pathologically harbor distinct microbial species and predictive inflammatory mediators
Demonstrate that when anastomotic tissues are lavaged with antibiotics directly via endoscopy ciprofloxacin metronidazole neomycin microbial pathogens that escape conventional antibiotics are eliminated and anastomotic healing progresses normally
Determine if the anastomotic healing score microbial analyses andor inflammatory mediator analyses identify or predict symptomatic and clinically relevant anastomotic complications
STUDY This is a randomized multicenter study All patients undergo resection of rectal cancer with a low anterior resection with anastomoses within 10cm of the anal verge and diverting ileostomy Patients will undergo three endoscopies one intra-operative endoscopy POD0 and two post-operative endoscopies POD3-7 POD12-28 POD post-operative day During the SES procedure the anastomosis will be lavaged with saline the fluid will be collected by suction images will be taken and then the anastomosis will be lavaged with either saline or an antibiotic solution composed of metronidazole ciprofloxacin and neomycin Patients clinical courses will be followed through chart review for 6 to 7 months following surgery
PROJECTED ACCRUAL A total of 200 patients approximately 100 per treatment arm will be accrued for this study within 4 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None