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Cola

Colonic resection with D2 lymph node dissection

Colonic resection with D3 lymph node dissection

Appropriate to the tumor location colonic resection is performed with D2 lymph node dissection

Appropriate to the tumor location colonic resection is performed with D3 lymph node dissection

Aleksei Karachun, Ph.D.

The purpose of this study is to determine wether D3 lymph node dissection gives superior oncological outcomes compared to standard D2 lymph node dissection in colon cancer

The design involves random allocation of eligible patients to D3 or D2 lymph node dissection group in 1:1 ratio. The extent of colonic resection itself is not influenced by the randomization and is predefined by the investigator prior to randomization.

Requirements applied to centers participating in the trial and surgeons performing procedures are described in the protocol and refer to center volume and surgeon's experience with evaluation of non-edited video-recordings of procedures.

Routine quality control includes requirement to photograph vessels with the clip to determine the extent of lymph node dissection performed and a thorough morphological assessment of the specimen.

After surgery patients are treated according to local standards with no difference wether D2 or D3 lymph node dissection was performed. Short-term and long-term outcomes are registered as per protocol.

This is a superiority trial evaluating statistical superiority. With the 50% five year survival according to national registry for colon cancer, expecting 10% improvement in survival with D3 lymph node dissection, enrollment of 768 patients during 3 year accrual period followed by 5 year follow up is required for a power of 80%.

The intent-to-treat principle is used for the data analysis.

Study of Oncological Outcomes of D3 Lymph Node Dissection in Colon Cancer

We are not planning to share personal patient data

Survival without local or systemic recurrence

Complex of parameters describing the pattern of recovery after surgery (i.e. food tolerance, peristalsis, walking etc.)

Number of lymph node with metastases related to number of lymph nodes studied in each group in the specimen

Ratio of good, satisfactory and unsatisfactory quality according to pathology report

Number of lymph nodes removed according to pathology report

CR29 and CR30 questionnaires by European Organization for Research and Treatment of Cancer

N.N. Petrov National Medical Research Center of Oncology

Cecal Neoplasms

Cecal Diseases

Ileocecal resection with extended D3 lymphadenectomy.

Right hemicolectomy with D3 lymphadenectomy

Laparoscopy ileocecal resectionith extended D3 lymphadenectomy including 201, 202, 203 and 213 groups of lymph nodes. Manual double-row ileo-ascendo-anastomosis.

ileocecal resection with extended D3 lymphadenectomy.

Laparoscopy right hemicolectomy with D3 lymphadenectomy including 201, 202, 203, 213, 211, 212, 221, 222-rt groups of lymph nodes. Manual double-row ileo-transverse-anastomosis.

Right hemicolectomy with D3 lymphadenectomy.

Igor Matveev

Mikhail Danilov

The purpose of this study is to determine the clinical efficacy, safety, and oncologic outcomes of ileocecal resection (ICR) with D3 lymphadenectomy compared to standard right hemicolectomy(RHC) for cecal cancer.

The design involves random allocation of eligible patients to ICR or RHC group in 1:1 ratio.

Requirements applied to centers participating in the trial and surgeons performing procedures are described in the protocol and refer to center volume and surgeon's experience.

Regular quality control includes the requirement to photograph the surgical specimen with a mark to determine the extent of lymphadenectomy performed and the number of the lymph node group.

After surgery patients are treated according to local standards, regardless of whether ICR or RHC was performed. Short-term and long-term outcomes are recorded according to the protocol.

Intervention. In all cases the tumor is localized in the area of the cecum; the border of the transition to the ascending colon is the upper lip of the ileocecal valve. The patient is not included in the study if the preoperative stage of examination reveals: synchronous cancer, distant metastasis (M1), locally advanced nature of the primary tumor (cT \> 3).

All patients will be randomly divided into two groups in a 1:1 ratio.

1. Research group (ICR) - Laparoscopy ileocecal resection with extended D3 lymphadenectomy (including 201, 202, 203 and 213 groups of lymph nodes). The minimum distance from the tumor is 10 cm, along the line of adequate blood supply. Next step - formation of a manual double-row ileo-ascendo-anastomosis.
2. Control group (RHC) - Laparoscopy right hemicolectomy with D3 lymphadenectomy (including 211, 212, 221, 222-rt groups of lymph nodes). Next step - formation of a manual double-row ileo-transverse-anastomosis.

Expected Results. The ICR will improve the short-term results of treatment of patients with cecal cancer compared with the standard RHC technique without affecting long-term results.

All patients will be randomly divided into two groups in a 1:1 ratio.

1. Research group (ICR) - Laparoscopy ileocecal resection with extended D3 lymphadenectomy (including 201, 202, 203 and 213 groups of lymph nodes). The minimum distance from the tumor is 10 cm, along the line of adequate blood supply. Next step - formation of a manual double-row ileo-ascendo-anastomosis.
2. Control group (RHC) - Laparoscopy right hemicolectomy with D3 lymphadenectomy (including 211, 212, 221, 222-rt groups of lymph nodes). Next step - formation of a manual double-row ileo-transverse-anastomosis.

Local Cecal Cancer - Optimization of Surgical Treatment

Study of the Oncological Outcomes of Ileocecal Resection With D3 for Cecal Cancer

We are not planning to share personal patient data.

X-ray assessment (Node-RADS classification) of clinical stage (N0 or N+) and distribution of suspicious lymph nodes into groups.

Questionnaires by European Organization for Research and Treatment of Cancer. EORTC QLQ - CR29.

Survival without local or distant recurrence.

Number of removed lymph nodes according to pathomorphological evaluation.

The ratio of affected lymph nodes into groups (201, 202, 203, 213, 211, 212, 221 or 222-rt) depending on the type of surgical treatment. Based on pathological assessment.

Average length of removed bowel in both groups according to pathomorphological evaluation (millimeters).

Average area of the removed mesentery in each groups according to pathomorphological evaluation (square centimetre - sq.cm).

Average blood loss during surgery in each group (ml).

Average operation time for each group (minutes - min).

The total number of conversions for each group.

Average number of days of inpatient treatment.

Moscow Clinical Scientific Center

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.

Elze Lockhorst, Drs.

Jennifer Schreinemakers, MD, PhD

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.

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

Age at surgery (years, min 18years-max 120 years)

American Society of Anaesthesiologists (ASA) score (I-V)

Bodyweight at hospital presentation (kilograms, min 30 - max 150)

Height (centimeters, min 120cm - max 230cm)

Concomitant and previous therapy for this tumour (chemotherapy/radiation)

C-reactive protein (CRP, mg/L) (0-500, higher score is worse)

Haemoglobin (Hb, g/dL) (1-12, lower score is worse)

Hematocrit (H, %) (0-100, the normal hematocrit for men is 40 to 54%; for women it is 36 to 48%)

Leukocytes (× 10\^9/L), the normal range is 4.5 to 11.0 × 109/L

Prothrombin time (PTT, seconds), normal range is 11 to 13.5 seconds

Sodium (mEq/L), normal range 135 to 145 milliequivalents per liter (mEq/L)

Potassium (mmol/L), normal range 3.6 to 5.2 millimoles per liter

Glomerular filtration rate (GFR, mL/min/1.73 m2), normal value \>90

Albumin (g/dL), normal range 3.5 to 5.5 grams per deciliter

Bilirubin (µmol/L), normal value less than 5.1 µmol/L

Alanine- Amino-Transferase (ASAT, U/L), normal range 8 to 33 U/L

Aspartate-Amino -transferase (ALAT, U/L), normal range 4 to 36 U/L

Lactic acid dehydrogenase (LDH,U/L), normal range 140 to 280 U/L

Alkaline phosphatase (ALP, IU/L), normal range 44 to 147

Gamma-GT (U/L), normal range 0 to 30 IU/L

Creatinkinase (U/L), norman range 22 to 198

Phosphate (mg/dL), normal range 2.5 to 4.5

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).

All complications (following Clavien-Dindo classification) within 90 days after hospitalisation

Days from admission untill day of surgery

Creation of primary anastomosis or stoma creation

Cancer stage (clinical and pathological) according to the tumour node metastasis (TNM) classification of the American Joint Committee

Total hospital stay (in total, after resection or reoperation) (days)

One year stoma rate, patients with a stoma after one year

Rate of patients with disease free survical one year postoperative based on radiological assessment

Rate of patients with disease free survical three year postoperative based on radiological assessment

Presence of metastases at the time of diagnosis

Endoscopy, CT-scan, ultrasound and/or MRI

Ileostomy, stent or nasogastric tube for decompression

Did the patient received additional nutrition?

Consultation of other specialist during hospital stay

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Oncological Outcomes of D3 Lymph Node Dissection in Colon Cancer	NCT03009227	Colonic Neoplas...	Colonic resecti... Colonic resecti...	18 Years -	N.N. Petrov National Medical Research Center of Oncology
Local Cecal Cancer - Optimization of Surgical Treatment	NCT06121089	Colonic Neoplas... Cecal Neoplasms	ileocecal resec... Right hemicolec...	18 Years -	Moscow Clinical Scientific Center
Local Cecal Cancer - Optimization of Surgical Treatment	NCT06121089	Colonic Neoplas... Cecal Neoplasms	ileocecal resec... Right hemicolec...	18 Years -	Moscow Clinical Scientific Center
Obstructive Colon Cancer, a Bridge to Surgery in Right Sided Obstructive Colon Cancer	NCT06338332	Colonic Neoplas...		18 Years -	Amphia Hospital

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