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TreatmENT of AnastomotiC Leakage After Esophagectomy

NCT03829098 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1509

Last updated 2022-04-01

No results posted yet for this study

Summary

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

  • Esophageal Cancer
  • Esophageal Neoplasms

Interventions

OTHER

Intervantions for anastomotic leakage after esophagectomy

nil by mouth regime; antibiotic treatment according to local protocols; NG tube placement (with/without suction); NG tube repositioning (with/without suction); tube placement though anastomotic defect; endoVAC/endoSponge placement; stent placement (stent type if applicable); endoscopic clipping; nasoduodenal/nasojejunal feeding tube placement; radiologic drainage (thoracic cavity, mediastinum); bedside surgical chest tube placement; reoperation; reoperation approach; reoperation procedure (drainage only, suturing of the leak; resection of the leak and re-anastomosis; repair of anastomosis with muscle flap; disconnection and cervical esophagostomy; surgical jejunal feeding tube).

Sponsors & Collaborators

  • Dutch Upper-GI Cancer Audit group (DUCA)

    collaborator UNKNOWN

  • Oesophago-Gastric Anastomosis Audit (OGAA)

    collaborator UNKNOWN

  • Radboud University Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2019-10-01
Completion
2019-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03829098 on ClinicalTrials.gov