Colon CancerNCT05734300
The "SPARCOL" Study
A study testing Combined Endoscopic Laparoscopic Surgery (CELS) and Standard resection in people with Colon Cancer and Frailty, run by Zealand University Hospital at 3 sites in Denmark.
Trial summary
Mortality following elective colorectal cancer surgery range between 2.5-6% and increase for the elderly and frail patient regardless of T-stage. Around 80% of the patients who present with a colon cancer and is in a condition where surgery is possible will be offered resection of the tumor. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Colon Cancer, Frailty
- What is being tested?
- Combined Endoscopic Laparoscopic Surgery (CELS) and Standard resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesDenmark
- Study dates
- 1 May 2023to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Male and Female participants providing written informed consent aged 75 years and older
- PS score ≥1 and /or ASA score ≥3
- Macroscopically or pathological colonic adenocarcinoma
- Clinical TNM classification T1/T2 N0 M0
- Eligible and suitable for CELS resection according to MDT
- Tumor must be located in colon, and not involving the ileac valve or taking up more than 50% of the lumen in an air-distended bowel wall
Who cannot join
- Unable to give informed consent
- Histological high-risk features in biopsy material from tumor (mucin, signet cells, de- differentiation)
- Suspected other malignancy than adenocarcinoma (e.g. neuroendocrine tumors)
- Preoperative chemo/radiotherapy
- Creation of stoma perioperative
- Non-Danish speakers
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites, 2 recruiting
- Active, not recruiting
Hospital Soenderjylland
Aabenraa, 6200
- Recruiting
Copenhagen University Hospital - Herlev
Copenhagen, Herlev, 2730
Mads Falk Klein, 38681543 ext. 0045, mads.falk.klein@regionh.dk
Henrik Loft Jacobsen
- Recruiting
Zealand University Hospital
Køge, 4600
Ilze Ose, Prof., 27293399 ext. 0045, ilos@regionsjaelland.dk
Ismail Gögenur, 26336426 ext. 0045, igo@regionsjaelland.dk
About this study
Official title: Organ SPARring Surgery vs. Standard Resection for Early Stage COLon Cancer in Elderly Frail Patients
Mortality following elective colorectal cancer surgery range between 2.5-6% and increase for the elderly and frail patient regardless of T-stage. Around 80% of the patients who present with a colon cancer and is in a condition where surgery is possible will be offered resection of the tumor. A part of the colon is always removed together with the lymph nodes in order to ensure that cancer cells are not left behind. The risk of lymph node metastasis is dependent on several histopathological characteristics of the tumor. The overall risk of lymph node metastases is less than 20 % in patients with early colon cancer. This indicates that the majority of patients with early colon cancer have no benefit of additional resection besides local tumor excision. The alternative to resecting a larger part of the bowel is to make more focused surgery only resecting a small part of the bowel part through a combination of laparoscopic and endoscopic techniques. This new organ sparing approach is called Combined Endoscopic Laparoscopic Surgery (CELS). The investigators aimed to examinate the hypothesis that organ preserving approach (CELS) provides superior quality of recovery in elderly frail patients with small colon cancers when compared with standard surgery in RCT.
- Conditions
- Colon Cancer, Frailty
- Being tested
- Combined Endoscopic Laparoscopic Surgery (CELS), Standard resection
- Keywords
- Colon Cancer, Elderly population, Early colo-rectal cancer, Organ Preserving Approach, Combined Endoscopic Laparoscopic Surgery (CELS)
- Medical subject headings
- Colonic Neoplasms, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Endoscopic Laparoscopic Surgery (CELS)Procedure or surgery
The main surgical advantage in this procedure is the ability to view the colon intra- and extraluminal simultaneously. The laparoscopic approach enables manipulation and mobilization of the colon, while the endoscopic view secures that the resection is complete and not overlapping the ileac valve or creating stenosis.
Compared to the traditional oncological colon resection, the CELS resection is a minimally invasive procedure - organ sparing procedure leading to a reduced surgical stress response.
Standard resectionProcedure or surgery
In this study standard resection of the colon will be performed according to complete mesocolic excision (CME) principles.
| Study group | Role | What they receive |
|---|---|---|
| CELS | Experimental | The Combined Endoscopic Laparoscopic Surgery (CELS) is a hybrid procedure that enables large local excisions of the colon without segmental resection while under general anaesthesia. In our study, CELS refers only to endoscopic assisted laparoscopic resection. Receives: Procedure: Combined Endoscopic Laparoscopic Surgery (CELS) |
| Standard Surgery | Active comparator | Standard surgical resection of colonic cancer following standard oncologic principles while under general anaesthesia. Receives: Procedure: Standard resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient-reported postoperative recovery - Quality of Recovery 15
Validated to measure recovery after surgery and general anesthesia, and additionally validated for use in Danish language and culture. The scale is arbitrary and ranges from 0 to 150. Higher scores means better recovery. The established minimum clinically important difference in QoR-15 is 8.0, and the SD of QoR- 15 scores after major surgery is in the order of 16.
Measured: Change in QoR-15 will be assessed repeatedly at baseline, 4-8 hours postoperatively (4-8H), postoperative day (POD) 1, POD 2, POD 3, POD 7, POD 10-14 and POD 30
Secondary outcomes (20)
Change in exercise capacity and physical condition
The 30 Second Sit to Stand Test. A measurement that assesses functional lower extremity strength in older adults. Test result is the number of times the participant comes to a full standing position in 30 seconds. Higher number of stands within 30 seconds means better result.
Measured: Changes will be assessed repeatedly at baseline, Postoperative day 1, Postoperative day 2, Postoperative day 3 or at the time of hospital discharge, whatever comes first. Postoperative day 10-14 and 30 days postoperatively.
Change in exercise capacity and physical condition
Six minutes' walk test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.
Measured: Changes will be assessed repeatedly at baseline, Postoperative day 1, Postoperative day 2, Postoperative day 3 or at the time of hospital discharge, whatever comes first. Postoperative day 10-14 and 30 days postoperatively.
Changes in The European Organization for Research and Treatment of Cancer quality of life questionnaire - EORTC C30.
EORTC C30, questionnaire, developed to assess the quality of life of cancer patients. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).
Measured: Changes will be assessed repeatedly at basline, 3 months, 6 months, 1 year follow-up
Changes in The European Organization for Research and Treatment of Cancer quality of life questionnaire- EORTC CRC.
EORTC CRC questionnaire, developed to assess the quality of life of cancer patients. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).
Measured: Changes will be assessed repeatedly at basline, 3 months, 6 months, 1 year follow-up
Frailty questionnaire Geriatric 8 (G8)
The G-8 Score is a screening tool containing 8 questions. The total G-8 score lies between 0 and 17. A higher score indicates a better health status.
Measured: Basline
Duration of surgery
Duration of surgery in minutes
Measured: Intraoperative
Blood loss
Blood loss in ml
Measured: Intraoperative
Intraoperative complications
Descriptive registration of intraoperative complications;
Measured: Intraoperative
Conversion rate
Conversion rate (%) from laparoscopic surgery to open surgery
Measured: Intraoperative
Rate of complete resection margin
R0 (tumor-free margin >1 mm) corresponds to resection for cure or complete remission. R1 to microscopic residual tumor, R2 to macroscopic residual tumor.
Measured: Postoperative day 14
Assessment of histopathological risk factors
Assessment of histopathological risk factor defined as presence of at least one of the risk factors: Kikuchi level ≥sm2, vascular invasion, lymphatic invasion, poorly differentiated adenocarcinoma, and tumour budding BD2-3.
Measured: Postoperative day 14
Long-term oncological outcomes: Disease-free survival
Time from surgery until the recurrence of disease or death
Measured: During 3-year follow-up periode
Long-term oncological outcomes: Overall survival
Overall survival was defined as the time elapsed from the date of surgery to the last day of follow-up or the date of death
Measured: During 3-year follow-up periode
Long-term oncological outcomes: Recurrence
Locoregional and/or distant recurrence after surgery defined as any histological, morphological, and clinical evidence of tumour growth during follow-up periode
Measured: During 3-year follow-up periode
Clavien-Dindo classification
Grading system used in surgery for grading adverse events (i.e. complications) which occur as a result of surgical procedures. Grade I to V, where V is death of the patient
Measured: Within 90 days postoperative.
The Comprehensive Complication Index
e Comprehensive Complication Index (CCI®) reflects the gravity of this overall complication burden on the patient on a scale from 0 (no complication) to 100 (death)
Measured: Within 90 days postoperative.
Length of hospital stay
Clinical metric that measures the length of time in days elapsed between a patient's hospital admittance and discharge.
Measured: Within 90 days postoperative.
90-day mortality
Death within 90 days after surgery, as either an inpatient or outpatient
Measured: Within 90 days postoperative.
Hospital readmissions
Unplanned readmissions that happen within 3 days of discharge from the index (i.e., initial) admission
Measured: Within 90 days postoperative.
Rate of secondary standard resection
Rate in percent of performed secondary surgery after primary CELS resection
Measured: Within 90 days postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start1 May 2023
- Primary completion1 May 2025 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734300
- Sponsor's protocol ID
- EMN 2022-04791
- Status last verified
- Jul 2023
- First submitted
- 16 Jan 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organ SPARring Surgery vs. Standard Resection for Early Stage COLon Cancer in Elderly Frail Patients
- ClinicalTrials.gov ID
- NCT05734300
- Acronym / sponsor ID
- EMN 2022-04791
- Conditions
- Colon Cancer, Frailty
- Keywords
- Colon Cancer, Elderly population, Early colo-rectal cancer, Organ Preserving Approach, Combined Endoscopic Laparoscopic Surgery (CELS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mortality following elective colorectal cancer surgery range between 2.5-6% and increase for the elderly and frail patient regardless of T-stage. Around 80% of the patients who present with a colon cancer and is in a condition where surgery is possible will be offered resection of the tumor. A part of the colon is always removed together with the lymph nodes in order to ensure that cancer cells are not left behind. The risk of lymph node metastasis is dependent on several histopathological characteristics of the tumor. The overall risk of lymph node metastases is less than 20 % in patients with early colon cancer. This indicates that the majority of patients with early colon cancer have no benefit of additional resection besides local tumor excision. The alternative to resecting a larger part of the bowel is to make more focused surgery only resecting a small part of the bowel part through a combination of laparoscopic and endoscopic techniques. This new organ sparing approach is called Combined Endoscopic Laparoscopic Surgery (CELS). The investigators aimed to examinate the hypothesis that organ preserving approach (CELS) provides superior quality of recovery in elderly frail patients with small colon cancers when compared with standard surgery in RCT.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CELS | Experimental | Procedure: Combined Endoscopic Laparoscopic Surgery (CELS)The Combined Endoscopic Laparoscopic Surgery (CELS) is a hybrid procedure that enables large local excisions of the colon without segmental resection while under general anaesthesia. In our study, CELS refers only to endoscopic assisted laparoscopic resection. |
| Standard Surgery | Active comparator | Procedure: Standard resectionStandard surgical resection of colonic cancer following standard oncologic principles while under general anaesthesia. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Male and Female participants providing written informed consent aged 75 years and older
- PS score ≥1 and /or ASA score ≥3
- Macroscopically or pathological colonic adenocarcinoma
- Clinical TNM classification T1/T2 N0 M0
- Eligible and suitable for CELS resection according to MDT
Key exclusion criteria (6 listed)
- Unable to give informed consent
- Histological high-risk features in biopsy material from tumor (mucin, signet cells, de- differentiation)
- Suspected other malignancy than adenocarcinoma (e.g. neuroendocrine tumors)
- Preoperative chemo/radiotherapy
- Creation of stoma perioperative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Endoscopic Laparoscopic Surgery (CELS)The main surgical advantage in this procedure is the ability to view the colon intra- and extraluminal simultaneously. The laparoscopic approach enables manipulation and mobilization of the colon, while the endoscopic view secures that the resection is complete and not overlapping the ileac valve or creating stenosis. Compared to the traditional oncological colon resection, the CELS resection is a minimally invasive procedure - organ sparing procedure leading to a reduced surgical stress response. | Procedure or surgery | CELS |
| Standard resectionIn this study standard resection of the colon will be performed according to complete mesocolic excision (CME) principles. | Procedure or surgery | Standard Surgery |
Primary outcome
Change in patient-reported postoperative recovery - Quality of Recovery 15
Time frame: Change in QoR-15 will be assessed repeatedly at baseline, 4-8 hours postoperatively (4-8H), postoperative day (POD) 1, POD 2, POD 3, POD 7, POD 10-14 and POD 30
Validated to measure recovery after surgery and general anesthesia, and additionally validated for use in Danish language and culture. The scale is arbitrary and ranges from 0 to 150. Higher scores means better recovery. The established minimum clinically important difference in QoR-15 is 8.0, and the SD of QoR- 15 scores after major surgery is in the order of 16.
20 secondary outcomes
Change in exercise capacity and physical condition
Time frame: Changes will be assessed repeatedly at baseline, Postoperative day 1, Postoperative day 2, Postoperative day 3 or at the time of hospital discharge, whatever comes first. Postoperative day 10-14 and 30 days postoperatively.
Change in exercise capacity and physical condition
Time frame: Changes will be assessed repeatedly at baseline, Postoperative day 1, Postoperative day 2, Postoperative day 3 or at the time of hospital discharge, whatever comes first. Postoperative day 10-14 and 30 days postoperatively.
Changes in The European Organization for Research and Treatment of Cancer quality of life questionnaire - EORTC C30.
Time frame: Changes will be assessed repeatedly at basline, 3 months, 6 months, 1 year follow-up
Changes in The European Organization for Research and Treatment of Cancer quality of life questionnaire- EORTC CRC.
Time frame: Changes will be assessed repeatedly at basline, 3 months, 6 months, 1 year follow-up
Frailty questionnaire Geriatric 8 (G8)
Time frame: Basline
Duration of surgery
Time frame: Intraoperative
Blood loss
Time frame: Intraoperative
Intraoperative complications
Time frame: Intraoperative
Conversion rate
Time frame: Intraoperative
Rate of complete resection margin
Time frame: Postoperative day 14
Assessment of histopathological risk factors
Time frame: Postoperative day 14
Long-term oncological outcomes: Disease-free survival
Time frame: During 3-year follow-up periode
Long-term oncological outcomes: Overall survival
Time frame: During 3-year follow-up periode
Long-term oncological outcomes: Recurrence
Time frame: During 3-year follow-up periode
Clavien-Dindo classification
Time frame: Within 90 days postoperative.
The Comprehensive Complication Index
Time frame: Within 90 days postoperative.
Length of hospital stay
Time frame: Within 90 days postoperative.
90-day mortality
Time frame: Within 90 days postoperative.
Hospital readmissions
Time frame: Within 90 days postoperative.
Rate of secondary standard resection
Time frame: Within 90 days postoperative.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Endoscopic Laparoscopic Surgery (CELS) and Standard resection in people with Colon Cancer and Frailty, run by Zealand University Hospital at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ilze Ose, MD (27293399 ext. 0045, ilos@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient-reported postoperative recovery - Quality of Recovery 15 (time frame: Change in QoR-15 will be assessed repeatedly at baseline, 4-8 hours postoperatively (4-8H), postoperative day (POD) 1, POD 2, POD 3, POD 7, POD 10-14 and POD 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.