An observational study in Colonic Neoplasms Malignant, sponsored by Amphia Hospital. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-29.
Sponsored by Amphia Hospital · Observational
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.
Approximately 13% (range 8-28%) presents with acute obstructing colorectal cancer (CRC). It's known that patients with acute obstructing CRC have increased mortality and morbidity compared to patients without acute obstructing CRC. Postoperative mortality ranges from 12 to 30%, which can raise to 41% in elderly patients with two or more additional risk factors. Morbidity rates until 78% are described in older patients undergoing emergency resection for obstructing CRC.
Different treatment options have been evaluated over the years. The two main options are; 1) emergency resection, simultaneous treatment of obstruction and tumour resection, 2) staged treatment of the obstruction with secondary resection of the tumour. Postoperative mortality after an emergency resection is known for its high risk of morbidity and mortality. From the Dutch audits it is know that the risk is high, not only for left sided obstruction, but also for right sided obstruction. Until recently, an acute emergency resection was the standard treatment for patients presenting with a small bowl ileus caused by a right sided colon cancer. However, more evidence has emerged that postponing surgery with a bridge tot surgery protocol can be beneficial to the patients. The bridge to surgery approach encompasses the utilization of either ileostomy creation or stent placement for colonic decompression, which is subsequently followed by definitive surgical treatment at a later stage. Alternatively, BTS may involve the introduction of a pause, also known as preoptimization, prior to the surgical procedure. The three main options for staged surgery all have its own up- and downsides. All forms of staged treatment appears to lead to fewer morbidity and mortality.
Emergency surgery Emergency resection is associated with a high risk of mortality and morbidity. Besides that, stoma creations after emergency surgery are higher than in patients treated electively. In case of a Hartmann's procedure, (resection of a left-sided tumour and creation of a colostomy) second surgical procedure is needed to restore continuity. Continuity restore has a mean mortality of 1% (range 0-7.4%) and morbidity of 16% (range 3-50%). Alternatively, emergency resection with primary anastomosis, which has the advantage to be a definite procedure, is performed. However, this treatment can be complicated with anastomotic leakage (AL). Anastomotic leakage is higher in patients treated for obstructing CRC in comparison with staged or electively treatment. Besides that, mortality rates after anastomotic leakage after colorectal surgery varies between 5-19%. Therefore, this intervention does not align with existing treatment strategies.
Bridge to surgery Stoma creation for colonic decompression followed by definite surgical treatment in a later stadium for patients with obstructing right sided CRC is an alternative. Postoperative mortality between patients treated with emergency resection, stent or stoma followed by resection showed no differences. However, high mortality rates in elderly patients (30%) after acute resection, stress the need for alternative strategies. For right-sided colon cancer, postoperative complications for patients treated with decompressing stoma before resection are lower in comparison with acute resection. However, the creation of an ileostomy leads to a longer hospital stay. Secondly, stenting as a bridge to surgery (BTS) creates time before definite surgical treatment. However, the use of stents as a bridge to surgery has controversial results. Stents as a BTS is associated with complications like perforation, stent migration, higher recurrence rate and re-obstruction. Furthermore, three prospective trials are closed prematurely because of high morbidity rates or a high number of technical failure of the self-expandable metallic stent (SEMS) However, several studies and one meta-analysis show promising short-term outcomes for the use of stents as BTS. Besides that, promising long-term outcomes, such as oncological safety, after stents as BTS are shown. Finally, transtumoral intubation for decompression of the colon, before initial can be considered to prevent stoma creation. Thirdly, a bridge to surgery may involve the introduction of a pause, also known as preoptimization, prior the surgical procedure. This previously presented as PRE-OCC, this approach appears feasible and safe. Deteriorating physical condition caused by poor intake, vomiting, changes in electrolyte status and weight loss often results in a decreased nutritional status. Nutritional status and thereby the patients preoperative health status seems to influence the mortality risk for patients with (obstructing) colorectal cancer. Creating a pause, before surgery provides a chance to optimise the patients' medical condition, perform a complete pre-operative screening of the patient's health status and examine possible concomitant illnesses. Besides nutritional status, also the functional capacity of the patient seems to be an important factor in postoperative mortality and morbidity. Studies, in elective colorectal surgery, show promising results after improving the functional capacity of patients (prehabilitation) on the recovery after colorectal surgery. However, this third option of bridge to surgery also has some disadvantages. Preoptimization leads to an prolonged duration of stay prior to surgery in a semi acute setting, with a central venous line and potentially insufficient decompression.
This study aims to determine whether implementation of bridge to surgery protocols is feasible and reduces mortality- and morbidity (stoma rates, major- and minor complications) rates in potentially curable patients presenting with acute obstructing CRC. By prospectively collecting the data, the feasibility of the protocols will be reported and the decrease in mortality and morbidity rates can be evaluated.
2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.
This study's planned enrollment of 110 is below the median of 227 across 555 observational studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Amphia Hospital is the lead sponsor of 13 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients admitted with high clinical suspicion of malignant obstruction of the right sided large bowel.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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).
Time frame: 90 days after hospitalization
Complications overall
All complications (following Clavien-Dindo classification) within 90 days after hospitalisation
Time frame: 90 days after hospitalization
Type of surgical intervention
Type of surgical intervention
Time frame: Day of surgery
Time till surgery
Days from admission untill day of surgery
Time frame: Days from admission untill day of surgery (up to 100 days)
Resection
Creation of primary anastomosis or stoma creation
Time frame: Day of the surgery
TNM
Cancer stage (clinical and pathological) according to the tumour node metastasis (TNM) classification of the American Joint Committee
Time frame: Day of the surgery
Hospital stay
Total hospital stay (in total, after resection or reoperation) (days)
Time frame: Days between surgery and moment of discharge (up to 100 days)
One year stoma rate
One year stoma rate, patients with a stoma after one year
Time frame: One year postoperative
One year survival rates
One year survival rates
Time frame: One years postoperative
Disease free survival rates one year
Rate of patients with disease free survical one year postoperative based on radiological assessment
Time frame: One years postoperative
Disease free survival rates three years
Rate of patients with disease free survical three year postoperative based on radiological assessment
Time frame: Three years postoperative
Three year survival rates
Three year survival rates
Time frame: Three years postoperative
Tumour type (obstructing, not obstructing),
Was there an obstructive tumor?
Time frame: At time of diagnosis
Metastasis preoperative
Presence of metastases at the time of diagnosis
Time frame: At time of diagnosis
Pre-operative diagnostics
Endoscopy, CT-scan, ultrasound and/or MRI
Time frame: At time of diagnosis
Type of bridge-to-surgery
Ileostomy, stent or nasogastric tube for decompression
Time frame: At time of diagnosis
Nutrition (TPN/extra nutrition)
Did the patient received additional nutrition?
Time frame: During hospital stay (up to 100 days)
Consultation of other specialist
Consultation of other specialist during hospital stay
Time frame: During hospital stay (up to 100 days)
Gender
male/female
Time frame: At time of diagnosis
Age at surgery
Age at surgery (years, min 18years-max 120 years)
Time frame: At time of diagnosis
ASA
American Society of Anaesthesiologists (ASA) score (I-V)
Time frame: At time of diagnosis
Bodyweight
Bodyweight at hospital presentation (kilograms, min 30 - max 150)
Time frame: At time of diagnosis
Height
Height (centimeters, min 120cm - max 230cm)
Time frame: At time of diagnosis
Concomitant and previous therapy
Concomitant and previous therapy for this tumour (chemotherapy/radiation)
Time frame: At time of diagnosis
C-reactive protein
C-reactive protein (CRP, mg/L) (0-500, higher score is worse)
Time frame: During hospital stay (up to 1 week postoperative)
Haemoglobin
Haemoglobin (Hb, g/dL) (1-12, lower score is worse)
Time frame: During hospital stay (up to 1 week postoperative)
Laboratory values
Hematocrit (H, %) (0-100, the normal hematocrit for men is 40 to 54%; for women it is 36 to 48%)
Time frame: During hospital stay (up to 1 week postoperative)
Leukocytes
Leukocytes (× 10\^9/L), the normal range is 4.5 to 11.0 × 109/L
Time frame: During hospital stay (up to 1 week postoperative)
Prothrombin time
Prothrombin time (PTT, seconds), normal range is 11 to 13.5 seconds
Time frame: During hospital stay (up to 1 week postoperative)
Sodium
Sodium (mEq/L), normal range 135 to 145 milliequivalents per liter (mEq/L)
Time frame: During hospital stay (up to 1 week postoperative)
Potassium
Potassium (mmol/L), normal range 3.6 to 5.2 millimoles per liter
Time frame: During hospital stay (up to 1 week postoperative)
Glomerular filtration rate
Glomerular filtration rate (GFR, mL/min/1.73 m2), normal value \>90
Time frame: During hospital stay (up to 1 week postoperative)
Albumin
Albumin (g/dL), normal range 3.5 to 5.5 grams per deciliter
Time frame: During hospital stay (up to 1 week postoperative)
Bilirubin
Bilirubin (µmol/L), normal value less than 5.1 µmol/L
Time frame: During hospital stay (up to 1 week postoperative)
ASAT
Alanine- Amino-Transferase (ASAT, U/L), normal range 8 to 33 U/L
Time frame: During hospital stay (up to 1 week postoperative)
ALAT
Aspartate-Amino -transferase (ALAT, U/L), normal range 4 to 36 U/L
Time frame: During hospital stay (up to 1 week postoperative)
LDH
Lactic acid dehydrogenase (LDH,U/L), normal range 140 to 280 U/L
Time frame: During hospital stay (up to 1 week postoperative)
ALP
Alkaline phosphatase (ALP, IU/L), normal range 44 to 147
Time frame: During hospital stay (up to 1 week postoperative)
Gamma-GT
Gamma-GT (U/L), normal range 0 to 30 IU/L
Time frame: During hospital stay (up to 1 week postoperative)
Creatinkinase
Creatinkinase (U/L), norman range 22 to 198
Time frame: During hospital stay (up to 1 week postoperative)
Phosphate
Phosphate (mg/dL), normal range 2.5 to 4.5
Time frame: During hospital stay (up to 1 week postoperative)
Lactate
Lactate (mg/dL), normal value \<1.0
Time frame: During hospital stay (up to 1 week postoperative)
Plan to share: Undecided
Started Jan 2024 (actual). Primary completion is estimated for Jan 2025, 12 months after the start.
Of 186 non-industry observational studies under Colonic Neoplasms, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 116. This study's planned 12 months is below that.
Counting every sponsor, half of 224 studies reached it within 50 months; a quarter within 24 and three quarters within 116.
How these figures are worked out, and which studies are left out of them.
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