TreatmENT of AnastomotiC Leakage After Esophagectomy

NCT03829098 | Completed

• 1 other identifier: TENTACLE
• Study Type: observational
• Target: 1,509
• Locations: 1 country
• Sites: 1

Brief 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. 1.To investigate what factors contribute to anastomotic leakage severity and to compose an evidence based anastomotic leakage severity score.
2. 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.

Conditions

Esophageal Cancer; Esophageal Neoplasms

Keywords

Anastomotic leakage

Outcome Measures

Primary Outcomes (1)

• 90 day mortality

  Mortality that occurs within 90 days after esophagectomy

  90 days

Secondary Outcomes (7)

• 30 day mortality

  30 days

• 180 day mortality

  180 days

• Comprehensive complications index (CCI)

  During admission for surgery or 30 days

• Reinterventions

  During admission for surgery or 30 days

• Hospital length of stay

  Total hospital length of stay without readmissions, assessed at 180 days

Interventions

Intervantions for anastomotic leakage after esophagectomy OTHER

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients with an anastomotic leakage after esophagectomy and gastric conduit reconstruction for esophageal cancer are suitable for inclusion.

You may qualify if:

• 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 \[Low 2015\].

You may not qualify if:

• Esophagectomy for benign disease;
• Emergency resection;
• Patients undergoing extended total gastrectomy.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Dutch Upper-GI Cancer Audit group (DUCA): collaborator
• Oesophago-Gastric Anastomosis Audit (OGAA): collaborator

Study Sites (1)

Radboudumc surgical department

Nijmegen, Netherlands

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Anastomotic Leak

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: February 4, 2019
• Study Start: April 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: December 31, 2019
• Last Updated: April 1, 2022

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 2 years after the main manuscript has been published
• Access Criteria: On request by collaborators only. Requests will be evaluated by the TENTACLE study team.

Locations

NL (1)