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Status unknownNCT06528054TENTACLE-ColonUpdated Jul 30, 2024

TreatmENT of AnastomotiC LeakagE After COLON Cancer Resection

An observational study in Treatment, Anastomotic Leakage and Resection, sponsored by Radboud University Medical Center. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-30.

Sponsored by Radboud University Medical Center · Observational

The sponsor has not verified this record recently (last verified Jul 2024), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
2,000
Ages
18 Years and older
Sex
All
01

Study 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 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.
  2. To explore and compare the effectiveness of various treatment strategies for AL following colon cancer resection, considering patient, tumour, resection and leakage characteristics.
02

Conditions studied

  • Treatment
  • Anastomotic Leakage
  • Resection
  • Colon Cancer
03

In context

Anastomotic Leak

218 studies on the registry are indexed under Anastomotic Leak; 62 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 194 across 114 observational studies indexed under Anastomotic Leak.

Browse Anastomotic Leak studies →

Lead sponsor

Radboud University Medical Center is the lead sponsor of 985 studies on the registry; 136 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Radboud University Medical Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients who developed AL after surgical resection with formation of primary anastomosis for colon cancer (cT1-4bN0-2M0-1).

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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion criteria:

  • 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)
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
2,000 participants (estimated)
Patient registry
No

Interventions

  • OtherDevelopment of a model for predicting 90-day mortality and to compare various treatment strategies for anastomotic leakage

    The prediction model and comparison of various treatment strategies will be studies when the data is available for analysis.

06

What researchers measure

Primary outcomes

  1. 90-day mortality

    mortality correlated with anastomotic leakage

    Time frame: 90 days after colon cancer resection

  2. 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)

    Time frame: 90 days after colon cancer resection

Secondary outcomes

  1. Time from colon cancer resection to diagnosis of anastomotic leakage

    Time frame: at least one year follow up

  2. Time from colon cancer resection to primary treatment of anastomotic leakage

    Time frame: at least one year follow up

  3. Length of hospital/intensive care unit stay

    Time frame: at least one year follow up

  4. Mortality

    Time frame: 30-day, 90-day and one-year after colon cancer resection

  5. Stoma presence (and if so, type of stoma)

    Time frame: At least one year after colon cancer resection, preferably last date of follow up

  6. Disease status

    Time frame: At least one year after colon cancer resection, preferably at last date of follow up

  7. Number of radiologic and surgical reinterventions

    Time frame: One year after colon cancer resection

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Individual participant data

Plan to share: 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2024; primary completion for Mar 2025, 5 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 24, 2024
First posted
Jul 30, 2024
StartEst.
Oct 2024
Primary completionEst.
Mar 2025
CompletionEst.
Mar 2026
Last update
Jul 30, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06528054
Lead sponsor
Radboud University Medical Center
Responsible party
Sponsor
First posted
Jul 30, 2024
Start date
Oct 2024 (estimated)
Primary completion
Mar 2025 (estimated)
Completion
Mar 2026 (estimated)
Last update
Jul 30, 2024

Study contacts

Jobbe Lemmens, MD
Contact
jobbe.lemmens@radboudumc.nl
00316 52331762
Hans de Wilt, Professor
principal investigator · Radboud University Medical Center
Pieter Tanis, Professor
principal investigator · Erasmus Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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