Clinical trial · Observational
TreatmENT of AnastomotiC Leakage After Esophagectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intervantions for anastomotic leakage after esophagectomy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 90 day mortality
- timeFrame
- 90 days
- description
- Mortality that occurs within 90 days after esophagectomy
Secondary outcomes (7)
- measure
- 30 day mortality
- timeFrame
- 30 days
- description
- Mortality that occurs within 30 days after esophagectomy
- measure
- 180 day mortality
- timeFrame
- 180 days
- description
- Mortality that occurs within 180 days after esophagectomy
- measure
- Comprehensive complications index (CCI)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 18 years or older; * Esophagectomy and gastric conduit reconstruction for resectable esophageal (cT1-4aN0-3M0) cancer; * Postoperative anastomotic leakage according to the ECCG definition \[Low 2015\]. Exclusion Criteria: * Esophagectomy for benign disease; * Emergency resection; * Patients undergoing extended total gastrectomy.
References
Publications (0)
Data not yet available