NCT03829098: TENTACLE

TreatmENT of AnastomotiC Leakage After Esophagectomy

Completed Last updated 1 April 2022

What this trial tests

trial testing Intervantions for anastomotic leakage after esophagectomy in Esophageal Cancer in 1,509 participants. Completed in 31 December 2019.

Timeline

1 April 2019

Primary endpoint
1 October 2019

31 December 2019

Quick facts

Lead sponsor	Radboud University Medical Center
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,509
Start date	1 April 2019
Primary completion	1 October 2019
Estimated completion	31 December 2019
Sites	1 location across Netherlands

Drugs / interventions tested

• Intervantions for anastomotic leakage after esophagectomy

Conditions studied

• Esophageal Cancer — all drugs for Esophageal Cancer →
• Esophageal Neoplasms — all drugs for Esophageal Neoplasms →

Sponsor

Radboud University Medical Center

Who can join

18 and older, any sex, with Esophageal Cancer or Esophageal Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Rationale: Anastomotic leakage (0% - 30%) is a severe complication after esophagectomy with mortality rates approximately ranging from 2% - 12%. In addition, it is associated with a prolonged ICU treatment and hospital stay. Anastomotic leakage severity is currently graded according to how it is treated (grade I: conservative treatment, grade II endoscopic or radiologic intervention and grade III surgical intervention). However, this scoring system cannot be used to guide decision making when anastomotic leakage is diagnosed in a clinical setting.

Factors that may influence the severity of the anastomotic leakage are (amongst others) location of the anastomosis, estimated surface of the defect, estimated circumference of the defect, extent of contamination, degree of sepsis and time from diagnosis until therapy. However, little is known about to what extent these and other factors contribute to anastomotic leakage severity. In addition, there is a paucity of data on what leakage characteristics dictate the success of a specific treatment.

Primary study objectives

1. To investigate what factors contribute to anastomotic leakage severity and to compose an evidence based anastomotic leakage severity score.
2. To investigate what anastomotic leakage characteristics are associated with success of different anastomotic leakage treatments and to compare the effectiveness of different initial anastomotic leakage treatments for leakages classified according to severity and leakage characteristics.

Study design: International multicenter retrospective cohort study.

Study population: Adult patients with anastomotic leakage after esophagectomy and gastric conduit reconstruction for esophageal cancer.

Cohort size: 1000-2000 patients with anastomotic leakage after esophagectomy for cancer.

Primary outcome parameter: 90 day mortality. Secondary outcome parameters: in-hospital mortality, 30-day mortality, 180-day mortality, comprehensive complications index, total number of reinterventions, hospital and ICU length of stay, hospital related costs.

Funding: Radboudumc

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Management of intrathoracic and cervical anastomotic leakage after esophagectomy for esophageal cancer: a systematic review.
   Verstegen MHP, Bouwense SAW, van Workum F, Ten Broek R, et al · · 2019 · cited 55× · PMID 30988695 · DOI 10.1186/s13017-019-0235-4
2. Severity of oEsophageal Anastomotic Leak in patients after oesophagectomy: the SEAL score.
   Ubels S, Verstegen M, Klarenbeek B, Bouwense S, et al · · 2022 · cited 16× · PMID 35759409 · DOI 10.1093/bjs/znac226
3. Treatment of anastomotic leak after oesophagectomy for oesophageal cancer: large, collaborative, observational TENTACLE cohort study.
   Ubels S, Verstegen MHP, Klarenbeek BR, Bouwense S, et al · · 2023 · cited 10× · PMID 37196149 · DOI 10.1093/bjs/znad123
4. Predicting mortality in patients with anastomotic leak after esophagectomy: development of a prediction model using data from the TENTACLE-Esophagus study.
   Ubels S, Klarenbeek B, Verstegen M, Bouwense S, et al · · 2023 · cited 7× · PMID 36461788 · DOI 10.1093/dote/doac081