Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04450758
Other study ID # Skane University Hospital
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date December 31, 2031

Study information

Verified date December 2023
Source Skane University Hospital
Contact Pamela Buchwald, PhD MD
Phone 004640331000
Email pamela.buchwald@med.lu.se
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

P) patients with acute obstructive colon cancer I) resection or bridge to surgery with stent or stoma C) emergency procedure O ) morbidity and mortality within 30 days, 90 day mortality and 3 & 5 years overall survival


Description:

The aim of this prospective observational study is to evaluate primary resection for malignant obstruction of the colon compared to only decompression as first intervention regarding postoperative outcomes. We hypothesize that patients with malignant obstruction benefit from avoidance of emergency cancer resection, by a two-stage procedure, with decompression by a stoma or stent as first intervention, leading to decreased short-term morbidity and mortality and improved long-term oncological outcome.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 31, 2031
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Age >18 years - Symptomatic large bowel obstruction requiring acute intervention - CT-verified colon obstruction due to colon cancer independent of presence of metastases - Informed consent Exclusion Criteria: - Colonic perforation or bleeding - Colonic obstruction of other origin than colon cancer - Palliative situation

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Bridge to Surgery (stent or stoma)
The study is an observational study and patients will not be randomized. Resection is defined as upfront surgical resection, Bridge to Surgery as a two stage procedure.

Locations

Country Name City State
Sweden Göteborg University Göteborg

Sponsors (2)

Lead Sponsor Collaborator
Skane University Hospital Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with 30-day severe morbidity Clavien-Dindo >3 within 30 days postop 30 days
Primary Overall survival after 3 years survival unspecified 3 years
Primary Number of patients with 30 day mortality death within 30 days 30 days
Primary Overall survival after 5 years survival unspecified 5 years
Primary Number of patients with 90 day mortality death within 90 days 90 days
Secondary Number of patients with locally radical resections resections regarded as R0 90 days
Secondary Number of examined mesenteric lymph nodes lymph nodes examined by pathologist 90 days
Secondary Proportion of patients receiving neoadjuvant or adjuvant treatment patients receiveing chemotherapy 1 year
Secondary Proportion of patients with stomas after 3 years patients with bowel continuity without stome 3 years
Secondary Recurrence rate after 3 after years relapse within 3 years 3 years
Secondary Disease-free survival after 3 years survival without disease relapse after 3 years 3 years
Secondary Proportion of patients not being subjected to resection of initially decompressed patients not proceeding to resection 90 days
Secondary bridging interval interval between stenting or stoma and resection 90 days
Secondary Number of stent complications (perforations, migration, bleeding, success rate etc) complications in stent group 90 days
Secondary Number of stoma complications complications in stoma group 90 days
Secondary Morbidity and survival and impact of tumour location 30 day morbidity and mortality depending on tumour location i.e. right or left colon 5 years
Secondary Number of laparoscopic resections numbers of laparoscopic vs open resections 90 days
Secondary Number of primary anastomosis number of primary anastomosis in the Bridge to Surgery vs up front resection group 90 days
Secondary Number of stomas after resection and type of stoma number of stomas in Bridge to Surgery vs up front resection group 90 days
Secondary total hospital stay in days days in hospital in Bridge to Surgery vs up front resection 90 days
Secondary colorectal surgeon performing resectional surgery qualified colorectal surgeon, general surgeon or resident performing resectional surgery 90 days
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05551052 - CRC Detection Reliable Assessment With Blood
Completed NCT03457454 - Reducing Rural Colon Cancer Disparities
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04088955 - A Digimed Oncology PharmacoTherapy Registry
Recruiting NCT06010862 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors Phase 1
Terminated NCT01347645 - Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer Phase 1/Phase 2
Completed NCT03390907 - Hybrid APC Assisted EMR for Large Colon Polyps N/A
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Completed NCT04079478 - The AID Study: Artificial Intelligence for Colorectal Adenoma Detection
Active, not recruiting NCT04057274 - Acute Effect of modeRate-intensity aerOBIc Exercise on Colon Cancer Cell Growth N/A
Recruiting NCT03190941 - Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients Phase 1/Phase 2
Not yet recruiting NCT05147545 - Impact of Exercise and Hyperlipidic Meal on Free Circulating DNA in Patients With Metastatic Colonic Cancer and Healthy Subjects N/A
Recruiting NCT05026268 - The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis N/A
Not yet recruiting NCT03277235 - Effect of a Resilience Model-Based Care Plan in Newly Diagnosed Colorectal Cancer Patients N/A
Active, not recruiting NCT02959541 - PK/PD Investigation of Calciumfolinat in Blood, Tumor and Adjacent Mucosa in Patient With Colon Cancer N/A
Active, not recruiting NCT02730702 - Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure
Completed NCT02810652 - Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection N/A
Recruiting NCT02577627 - Multi-Indication, Retrospective Oncological Study to Validate the Accuracy in Predicting TTP by PrediCare in Patients Under SOC N/A
Terminated NCT02628535 - Safety Study of MGD009 in B7-H3-expressing Tumors Phase 1
Recruiting NCT02526836 - Complete Mesocolic Excision With Central Vessel Ligation Compared With Conventional Surgery for Colon Cancer Phase 2/Phase 3