Obstructive Colon Cancer, a Bridge to Surgery in Right Sided Obstructive Colon Cancer

NCT06338332 | Recruiting

• 1 other identifier: AW23.050, W19.249
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Approximately 13% (range 10-28%) of all colorectal cancer patients (CRC) present with an acute obstruction. Postoperative mortality after an emergency resection is known for its high risk of morbidity and mortality. Different options can be considered in the management of obstructing right sided CRC: 1) primary resection, simultaneous treatment of obstruction and tumour resection, or 2) staged treatment of the obstruction with secondary resection of the tumour. Currently, in the Netherlands, an emergency resection has been judged to be inferior to postponing surgery. Patients who present with right sided obstructive colon cancer at one of the participating hospitals are subjected to a bridge to surgery (BTS) protocol. Objective: The primary objective of this study is to determine the feasibility of BTS protocols in right sided obstructive colon cancer and reduce mortality- and morbidity (stoma rates, major- and minor complications) rates in potentially curable patients presenting with acute obstructing colon cancer. Study design: This is a multicentre, prospective registration study Study population: All patients presenting with high clinical suspicion or histologically proven right sided colon cancer and signs of obstruction of the large bowel. Intervention: Prospective registration of the implementation of bridge to surgery protocols in patients with (acute) malignant right sided obstruction of the colon, without suspicion of perforation (tumour perforation or blow out) in order to optimize patients preoperatively. The BTS approach encompasses the utilization of either ileostomy creation, stent placement or nasogastric tube for decompression, which is subsequently followed by definitive surgical treatment at a later stage. BTS also involves pre-optimization, prior to the surgical procedure, with the following approach: optimizing the nutritional health status improving the physical health status of the patient. Main study parameters/endpoints: The primary endpoint is complication-free survival (CFS) at 90 days after hospitalization. Complication is defined here as mortality and/or development of a major complication (Clavien-Dindo classification ≥3). With a total follow up of three years. Secondary endpoints: overall mortality, morbidity (stoma rates, minor complications), in hospital stay, oncologic quality of resection and other occurring adverse events.

Conditions

Colonic Neoplasms Malignant

Keywords

Right-sided; Bridge-to-surgery; Obstructive

Outcome Measures

Primary Outcomes (1)

• Complication-free survival

  The primary endpoint is complication-free survival (CFS) at 90 days after hospitalization. Complication is defined here as mortality and/or development of a major complication (Clavien-Dindo classification ≥3).

  90 days after hospitalization

Secondary Outcomes (17)

• Complications overall

  90 days after hospitalization

• Type of surgical intervention

  Day of surgery

• Time till surgery

  Days from admission untill day of surgery (up to 100 days)

• Resection

  Day of the surgery

• TNM

  Day of the surgery

Other Outcomes (24)

• Gender

  At time of diagnosis

• Age at surgery

  At time of diagnosis

• ASA

  At time of diagnosis

Study Arms (3)

Nasogastric tube

Patients with right sided obstructive colon cancer will receive non-surgical decompression with a nasogastric probe. Prior to the definitive oncological resection, patients undergo preoperative optimisation which involves the engagement of a dietician and physiotherapist. Patients eligible for elective resection will have their resection 7-10 days after initial decompression.

Ileostomy

Patients with right sided obstructive colon cancer will receive a ileostomy. Prior to the definitive oncological resection, patients undergo preoperative optimisation which involves the engagement of a dietician and physiotherapist. Patients eligible for elective resection will be operated at least 7 days after initial decompression and no later than 4 weeks after initial presentation.

Right-sided stent

Patients with right sided obstructive colon cancer will receive a right-sided stent. Prior to the definitive oncological resection, patients undergo preoperative optimisation which involves the engagement of a dietician and physiotherapist. Patients eligible for elective resection will be operated at least 7 days after initial decompression and no later than 4 weeks after initial presentation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients admitted with high clinical suspicion of malignant obstruction of the right sided large bowel.

You may qualify if:

• Patients age is 18 years or older
• Patients presenting with symptoms of obstruction (including cecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid colon) caused by (high suspicion or histologically proven) colonic cancer.
• Patient presenting with symptoms of partial obstruction (abdominal pain, nausea, vomiting, diarrhoea) confirmed by the presence of a dilated colon or ileum with a computed tomography (CT-scan).
• Treatment with curative intent.

You may not qualify if:

• Obstruction of the colon pathologically caused by benign disease.
• Obstruction of the colon caused by an extra-colonic malignancy.
• Suspicion of emergency complications caused by peritonitis due to perforation (tumour or blow out) or sepsis.
• Patients with advanced disease who will undergo a palliative trajectory.
• Rectal cancer

Sponsors & Collaborators

• Amphia Hospital: lead

Study Sites (1)

Amphia Hospital

Breda, North Brabant, 4818CK, Netherlands

RECRUITING

Related Publications (35)

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Study Officials

• Jennifer Schreinemakers, MD, PhD

  Amphia Hospital Breda, The Netherlands

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elze Lockhorst, Drs.

CONTACT

+31613723827; elockhorst@amphia.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 29, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 29, 2024

Record last verified: 2024-02

Locations

NL (1)