Study design:
The local ethics committee of Tübingen University Hospital, Germany, approved this study (AZ: 752/2019BO2). The study is registered with ClinicalTrials.gov under reference number NCT04362605. The study is adheres to the PROCESS guidelines from 2016.
All EJAL patients treated primarily with ENPT between January 2018 and December 2019 were considered for the study. Ethics Approval and Consent to Participate whether informed consent was obtained from all participants. Patients’ records as well as the database were analyzed for EJAL therapy-specific items. EJAL is defined according to the definition of anastomotic insufficiencies following esophageal or cardial resection of 2018 [16].
Endoscopic negative pressure therapy (ENPT):
OPD: The commercially available Eso-SPONGE® System (B. Braun Melsungen AG, Melsungen, Germany) was used for endoluminal vacuum therapy. For positioning the OPD in loop-technique a loop (MersileneTM, Polyester, 4 Ph. Eur., Ethicon®, Norderstedt, Germany) is fixed at the distal end of the drain, gripped with an endoscopic grasper and placed under endoscopic view. Endoscopic placement was performed via oral intubation of the esophagus and finally with oro-nasal redirection and fixation with plasters. The OPD with placed suture loop is illustrated in Figure 1.
OFD: The OFD for endoluminal therapy is handmade, as previously described by G. Loske et al. [11], by wrapping a thin open-pore double-layered drainage film (Suprasorb® CNP, Drainage Film; Lohmann & Rauscher International GmbH & Co.KG, Rengsdorf, Germany) around the distal end of a small caliber redon drain, a gastric tube or the gastric segment of a naso-jejunal feeding tube (Freka® Trelumina, Fresenius Kabi Deutschland GmbH, Bad Homburg, Germany). Sutures (MersileneTM, Polyester, 4 Ph. Eur., Ethicon®, Norderstedt, Germany) were used for fixation of the drainage film around the tube. Drain insertion took place via nasal positioning and endoscopic guiding with a grasper. Venting tubes in tri-lumen enteral feeding tubes had to be closed for ENPT. The handmade OFD on an intestinal feeding tube is shown in Figure 2.
Controlled Negative Pressure: A continuous vacuum of -125 mmHg is generated with electronic vacuum devices (KCI V.A.C. Ulta or V.A.C. Freedom; KCI USA Inc., San Antonio, TX, USA).
Procedural information: In patients with suspected EJAL first an index endoscopy was performed under general anesthesia with endotracheal intubation. Standard gastroscopes with an outer diameter of 9.8mm were used with carbon dioxide insufflation.
Definition of an anastomotic leak is based on the endoscopic finding at the esophago-jejunostomy according to the CAES classification [16]. Extraluminal fluids and gases are radiologically assessed. Decision criteria for placement of OPD or OFD were the defect size, the extension of extraluminal collection and the patient’s clinical condition. A CT scan in patients with suspected EJAL was done in all cases before or after endoscopy. Extraluminal collections were drained via limited surgical procedure as part of the presented concept.
Re-endoscopy and ENPT device change were performed after three to seven days until resolution of the complication. In patients with OPD change interval was three to four days, while in patients treated with OFD the interval was longer, namely up to seven days. Success was defined as complete closure of the perforation.
In patients with a compensated clinical condition and endoluminal OFD the swallowing of liquids is allowed.
Database:
An analysis was performed using SPSS v. 24.0.0.1 (IBM, Armonk, NY, USA). Data were presented as means ± SD.