TreatmentTENTACLE-ColonNCT06528054
TreatmENT of AnastomotiC LeakagE After COLON Cancer Resection
An observational study of Treatment and Anastomotic Leakage, run by Radboud University Medical Center.
Trial summary
This international multicentre retrospective cohort study aims to research anastomotic leakage after colon cancer resection and has two main objectives: 1. To identify predictive factors associated with 90-day mortality and 90-day Clavien-Dindo grade 4-5 complications amongst patients who developed AL following colon… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment, Anastomotic Leakage, Resection
- What is being tested?
- Development of a model for predicting 90-day mortality and to compare various treatment strategies for anastomotic leakage
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who developed AL after surgical resection with formation of primary anastomosis for colon cancer (cT1-4bN0-2M0-1).
Who may be able to join
- Aged 18 years or older;
- Surgical resection for primary colon cancer (cT1-4b, N0-2, M0-1) with formation of a primary colonic anastomosis and with or without diverting stoma;
- Postoperative AL defined as: "any clinical, radiological or intraoperative signs of disrupted integrity of the anastomosis. This also includes suspected leaks with any degree of extraluminal air or fluid on CT, perianastomotic abscess, purulent peritonitis without clear anastomotic defect, or any other suspicious condition in which there is no ultimate macroscopic proof of disrupted anastomosis."
- Regarding the type of colon cancer resection, the following patients will also fulfil the inclusion criteria: patients who underwent cytoreductive surgery (CRS) simultaneous with resection of the primary colon cancer with or without hyperthermic intraperitoneal chemotherapy (HIPEC), simultaneous ablations/resections of metastasis, multivisceral resection, emergency resection, patients diagnosed with perforated disease/peritumoral abscess or fistula, and acute obstructions.
Who cannot join
- Surgical resection for benign colon disease;
- Recurrent colon cancer resection;
- Any primary colon malignancy other than adenocarcinoma (e.g. neuroendocrine tumour, gastrointestinal stromal tumour);
- Any clinical condition that does not fulfil the broad definition of AL as used in this study (e.g. only free air on CT that is considered to be compatible with an appropriate postoperative day in the absence of any other clinical signs related to a potential anastomotic leakage)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: TreatmENT of AnastomotiC LeakagE After COLON Cancer Resection: the TENTACLE - Colon Study
This international multicentre retrospective cohort study aims to research anastomotic leakage after colon cancer resection and has two main objectives:
- To identify predictive factors associated with 90-day mortality and 90-day Clavien-Dindo grade 4-5 complications amongst patients who developed AL following colon cancer resection and to develop and validate a prediction model for predicting 90-day mortality as well as the co-primary composite endpoint Clavien-Dindo grade 4-5 complications.
- To explore and compare the effectiveness of various treatment strategies for AL following colon cancer resection, considering patient, tumour, resection and leakage characteristics.
- Conditions
- Treatment, Anastomotic Leakage, Resection, Colon Cancer
- Being tested
- Development of a model for predicting 90-day mortality and to compare various treatment strategies for anastomotic leakage
- Medical subject headings
- Anastomotic Leak, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Development of a model for predicting 90-day mortality and to compare various treatment strategies for anastomotic leakageOther
The prediction model and comparison of various treatment strategies will be studies when the data is available for analysis.
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day mortality
mortality correlated with anastomotic leakage
Measured: 90 days after colon cancer resection
90-day Clavien-Dindo grade IV - V complications
This composite co-primary outcome consists of single-organ failure (i.e. grade IV) and mortality (i.e. grade V)
Measured: 90 days after colon cancer resection
Secondary outcomes (7)
Time from colon cancer resection to diagnosis of anastomotic leakage
Measured: at least one year follow up
Time from colon cancer resection to primary treatment of anastomotic leakage
Measured: at least one year follow up
Length of hospital/intensive care unit stay
Measured: at least one year follow up
Mortality
Measured: 30-day, 90-day and one-year after colon cancer resection
Stoma presence (and if so, type of stoma)
Measured: At least one year after colon cancer resection, preferably last date of follow up
Disease status
Measured: At least one year after colon cancer resection, preferably at last date of follow up
Number of radiologic and surgical reinterventions
Measured: One year after colon cancer resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study startOct 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TreatmentStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hans de Wilt, Professor, Principal investigator, Radboud University Medical CenterPieter Tanis, Professor, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528054
- Sponsor's protocol ID
- 2024-3-2500
- Acronym
- TENTACLE-Colon
- Status last verified
- Jul 2024
- First submitted
- 24 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data may be available upon reasonable request. Only collaborators with appropriate qualifications and pertinent research inquiries are eligible to request access to the data. The principal investigators of the TENTACLE - Colon study will assess the relevance and appropriateness of the request and their verdict is decisive. If data will be transferred, it will solely be conducted under the appropriate ethical and data transfer agreement.
Publications
Lemmens JMG, Ubels S, Greijdanus NG, Wienholts K, van Gelder MMHJ, Wolthuis A, Lefevre JH, Brown K, Frasson M, Rotholtz N, Denost Q, Perez RO, Konishi T, Rutegard M, Gearhart SL, Pinkney T, Elhadi M, Hompes R, Tanis PJ, de Wilt JHW. TreatmENT of AnastomotiC LeakagE after colon cancer resection: the TENTACLE - Colon study. BMC Surg. 2025 May 15;25(1):213. doi: 10.1186/s12893-025-02954-1.
PubMed 40375249
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TreatmENT of AnastomotiC LeakagE After COLON Cancer Resection: the TENTACLE - Colon Study
- ClinicalTrials.gov ID
- NCT06528054
- Acronym / sponsor ID
- TENTACLE-Colon / 2024-3-2500
- Conditions
- Treatment, Anastomotic Leakage, Resection, Colon Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 30 Jul 2024 (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.
This international multicentre retrospective cohort study aims to research anastomotic leakage after colon cancer resection and has two main objectives:
- To identify predictive factors associated with 90-day mortality and 90-day Clavien-Dindo grade 4-5 complications amongst patients who developed AL following colon cancer resection and to develop and validate a prediction model for predicting 90-day mortality as well as the co-primary composite endpoint Clavien-Dindo grade 4-5 complications.
- To explore and compare the effectiveness of various treatment strategies for AL following colon cancer resection, considering patient, tumour, resection and leakage characteristics.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who developed AL after surgical resection with formation of primary anastomosis for colon cancer (cT1-4bN0-2M0-1).
Key inclusion criteria (4 listed)
- Aged 18 years or older;
- Surgical resection for primary colon cancer (cT1-4b, N0-2, M0-1) with formation of a primary colonic anastomosis and with or without diverting stoma;
- Postoperative AL defined as: "any clinical, radiological or intraoperative signs of disrupted integrity of the anastomosis. This also includes suspected leaks with any degree of extraluminal air or fluid on CT, perianastomotic abscess, purulent peritonitis without clear anastomotic defect, or any other suspicious condition in which there is no ultimate macroscopic proof of disrupted anastomosis."
- Regarding the type of colon cancer resection, the following patients will also fulfil the inclusion criteria: patients who underwent cytoreductive surgery (CRS) simultaneous with resection of the primary colon cancer with or without hyperthermic intraperitoneal chemotherapy (HIPEC), simultaneous ablations/resections of metastasis, multivisceral resection, emergency resection, patients diagnosed with perforated disease/peritumoral abscess or fistula, and acute obstructions.
Key exclusion criteria (4 listed)
- Surgical resection for benign colon disease;
- Recurrent colon cancer resection;
- Any primary colon malignancy other than adenocarcinoma (e.g. neuroendocrine tumour, gastrointestinal stromal tumour);
- Any clinical condition that does not fulfil the broad definition of AL as used in this study (e.g. only free air on CT that is considered to be compatible with an appropriate postoperative day in the absence of any other clinical signs related to a potential anastomotic leakage)
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 |
|---|---|---|
| Development of a model for predicting 90-day mortality and to compare various treatment strategies for anastomotic leakageThe prediction model and comparison of various treatment strategies will be studies when the data is available for analysis. | Other | – |
Primary outcome
90-day mortality
Time frame: 90 days after colon cancer resection
mortality correlated with anastomotic leakage
90-day Clavien-Dindo grade IV - V complications
Time frame: 90 days after colon cancer resection
This composite co-primary outcome consists of single-organ failure (i.e. grade IV) and mortality (i.e. grade V)
7 secondary outcomes
Time from colon cancer resection to diagnosis of anastomotic leakage
Time frame: at least one year follow up
Time from colon cancer resection to primary treatment of anastomotic leakage
Time frame: at least one year follow up
Length of hospital/intensive care unit stay
Time frame: at least one year follow up
Mortality
Time frame: 30-day, 90-day and one-year after colon cancer resection
Stoma presence (and if so, type of stoma)
Time frame: At least one year after colon cancer resection, preferably last date of follow up
Disease status
Time frame: At least one year after colon cancer resection, preferably at last date of follow up
Number of radiologic and surgical reinterventions
Time frame: One year after colon cancer resection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Derived from this study: PubMed 40375249Lemmens JMG, Ubels S, Greijdanus NG, Wienholts K, van Gelder MMHJ, Wolthuis A, Lefevre JH, Brown K, Frasson M, Rotholtz N, Denost Q, Perez RO, Konishi T, Rutegard M, Gearhart SL, Pinkney T, Elhadi M, Hompes R, Tanis PJ, de Wilt JHW. TreatmENT of AnastomotiC LeakagE after colon cancer resection: the TENTACLE - Colon study. BMC Surg. 2025 May 15;25(1):213. doi: 10.1186/s12893-025-02954-1.
- Individual participant dataSharing planned: Undecided. Data may be available upon reasonable request. Only collaborators with appropriate qualifications and pertinent research inquiries are eligible to request access to the data. The principal investigators of the TENTACLE - Colon study will assess the relevance and appropriateness of the request and their verdict is decisive. If data will be transferred, it will solely be conducted under the appropriate ethical and data transfer agreement.
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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. This study is not recruiting at the moment.
Hans de Wilt, Professor principal investigator
Radboud University Medical Center
Pieter Tanis, Professor principal investigator
Erasmus Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Treatment and Anastomotic Leakage, run by Radboud University Medical Center.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jobbe Lemmens, MD (00316 52331762, jobbe.lemmens@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-day mortality (time frame: 90 days after colon cancer resection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06528054, which also lists 1 linked publication.
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 30 Jul 2024.