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

Colonic Neoplasms Malignant Clinical Trial

— OCCBRIGHT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06338332
• Other study ID #: AW23.050, W19.249
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: January 2028

Study information

• Verified date: February 2024
• Source: Amphia Hospital
• Contact: Elze Lockhorst, Drs.
• Phone: +31613723827
• Email: elockhorst[@]amphia.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: January 2028
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colonic Neoplasms Malignant
• Neoplasms

Locations

Country	Name	City	State
Netherlands	Amphia Hospital	Breda	Noord-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Amphia Hospital

Country where clinical trial is conducted

Netherlands, 

References & Publications (35)

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gender	male/female	At time of diagnosis
Other	Age at surgery	Age at surgery (years, min 18years-max 120 years)	At time of diagnosis
Other	ASA	American Society of Anaesthesiologists (ASA) score (I-V)	At time of diagnosis
Other	Bodyweight	Bodyweight at hospital presentation (kilograms, min 30 - max 150)	At time of diagnosis
Other	Height	Height (centimeters, min 120cm - max 230cm)	At time of diagnosis
Other	Concomitant and previous therapy	Concomitant and previous therapy for this tumour (chemotherapy/radiation)	At time of diagnosis
Other	C-reactive protein	C-reactive protein (CRP, mg/L) (0-500, higher score is worse)	During hospital stay (up to 1 week postoperative)
Other	Haemoglobin	Haemoglobin (Hb, g/dL) (1-12, lower score is worse)	During hospital stay (up to 1 week postoperative)
Other	Laboratory values	Hematocrit (H, %) (0-100, the normal hematocrit for men is 40 to 54%; for women it is 36 to 48%)	During hospital stay (up to 1 week postoperative)
Other	Leukocytes	Leukocytes (× 10^9/L), the normal range is 4.5 to 11.0 × 109/L	During hospital stay (up to 1 week postoperative)
Other	Prothrombin time	Prothrombin time (PTT, seconds), normal range is 11 to 13.5 seconds	During hospital stay (up to 1 week postoperative)
Other	Sodium	Sodium (mEq/L), normal range 135 to 145 milliequivalents per liter (mEq/L)	During hospital stay (up to 1 week postoperative)
Other	Potassium	Potassium (mmol/L), normal range 3.6 to 5.2 millimoles per liter	During hospital stay (up to 1 week postoperative)
Other	Glomerular filtration rate	Glomerular filtration rate (GFR, mL/min/1.73 m2), normal value >90	During hospital stay (up to 1 week postoperative)
Other	Albumin	Albumin (g/dL), normal range 3.5 to 5.5 grams per deciliter	During hospital stay (up to 1 week postoperative)
Other	Bilirubin	Bilirubin (µmol/L), normal value less than 5.1 µmol/L	During hospital stay (up to 1 week postoperative)
Other	ASAT	Alanine- Amino-Transferase (ASAT, U/L), normal range 8 to 33 U/L	During hospital stay (up to 1 week postoperative)
Other	ALAT	Aspartate-Amino -transferase (ALAT, U/L), normal range 4 to 36 U/L	During hospital stay (up to 1 week postoperative)
Other	LDH	Lactic acid dehydrogenase (LDH,U/L), normal range 140 to 280 U/L	During hospital stay (up to 1 week postoperative)
Other	ALP	Alkaline phosphatase (ALP, IU/L), normal range 44 to 147	During hospital stay (up to 1 week postoperative)
Other	Gamma-GT	Gamma-GT (U/L), normal range 0 to 30 IU/L	During hospital stay (up to 1 week postoperative)
Other	Creatinkinase	Creatinkinase (U/L), norman range 22 to 198	During hospital stay (up to 1 week postoperative)
Other	Phosphate	Phosphate (mg/dL), normal range 2.5 to 4.5	During hospital stay (up to 1 week postoperative)
Other	Lactate	Lactate (mg/dL), normal value <1.0	During hospital stay (up to 1 week postoperative)
Primary	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	Complications overall	All complications (following Clavien-Dindo classification) within 90 days after hospitalisation	90 days after hospitalization
Secondary	Type of surgical intervention	Type of surgical intervention	Day of surgery
Secondary	Time till surgery	Days from admission untill day of surgery	Days from admission untill day of surgery (up to 100 days)
Secondary	Resection	Creation of primary anastomosis or stoma creation	Day of the surgery
Secondary	TNM	Cancer stage (clinical and pathological) according to the tumour node metastasis (TNM) classification of the American Joint Committee	Day of the surgery
Secondary	Hospital stay	Total hospital stay (in total, after resection or reoperation) (days)	Days between surgery and moment of discharge (up to 100 days)
Secondary	One year stoma rate	One year stoma rate, patients with a stoma after one year	One year postoperative
Secondary	One year survival rates	One year survival rates	One years postoperative
Secondary	Disease free survival rates one year	Rate of patients with disease free survical one year postoperative based on radiological assessment	One years postoperative
Secondary	Disease free survival rates three years	Rate of patients with disease free survical three year postoperative based on radiological assessment	Three years postoperative
Secondary	Three year survival rates	Three year survival rates	Three years postoperative
Secondary	Tumour type (obstructing, not obstructing),	Was there an obstructive tumor?	At time of diagnosis
Secondary	Metastasis preoperative	Presence of metastases at the time of diagnosis	At time of diagnosis
Secondary	Pre-operative diagnostics	Endoscopy, CT-scan, ultrasound and/or MRI	At time of diagnosis
Secondary	Type of bridge-to-surgery	Ileostomy, stent or nasogastric tube for decompression	At time of diagnosis
Secondary	Nutrition (TPN/extra nutrition)	Did the patient received additional nutrition?	During hospital stay (up to 100 days)
Secondary	Consultation of other specialist	Consultation of other specialist during hospital stay	During hospital stay (up to 100 days)