TreatmENT of AnastomotiC LeakagE After COLON Cancer Resection (TENTACLE-Colon)

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:

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colon Cancer; Treatment; Anastomotic Leakage; Resection
• Intervention / Treatment: Other: Development of a model for predicting 90-day mortality and to compare various treatment strategies for anastomotic leakage

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Jobbe Lemmens, MD; Phone Number: 00316 52331762; Email: jobbe.lemmens@radboudumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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).

Description

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:

• 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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
90-day mortality	mortality correlated with anastomotic leakage	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)	90 days after colon cancer resection

Secondary Outcome Measures

Outcome Measure	Time Frame
Time from colon cancer resection to diagnosis of anastomotic leakage	at least one year follow up
Time from colon cancer resection to primary treatment of anastomotic leakage	at least one year follow up
Length of hospital/intensive care unit stay	at least one year follow up
Mortality	30-day, 90-day and one-year after colon cancer resection
Stoma presence (and if so, type of stoma)	At least one year after colon cancer resection, preferably last date of follow up
Disease status	At least one year after colon cancer resection, preferably at last date of follow up
Number of radiologic and surgical reinterventions	One year after colon cancer resection

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Investigators: Principal Investigator: Hans de Wilt, Professor, Radboud University Medical Center; Principal Investigator: Pieter Tanis, Professor, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: July 24, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Postoperative Complications; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Anastomotic Leak; Colonic Neoplasms
• Other Study ID Numbers: 2024-3-2500

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No