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Stent Placement for Benign Esophageal Leaks, Perforations, and Fistulae: a Clinical Prediction Rule for Successful Leakage Control

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Stent Placement for Benign Esophageal Leaks, Perforations, and Fistulae: a Clinical Prediction Rule for Successful Leakage Control Original article Stent placement for benign esophageal leaks, perforations, and fistulae: a clinical prediction rule for successful leakage control Authors Emo E. van Halsema1,WouterF.W.Kappelle2,BasL.A.M.Weusten3, Robert Lindeboom4, Mark I. van Berge Henegouwen5,PaulFockens1, Frank P. Vleggaar2, Manon C. W. Spaander6,JeaninE.vanHooft1 Institutions Scan this QR-Code for the authorʼs interview. 1 Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, the Netherlands 2 Department of Gastroenterology and Hepatology, University Medical Center Utrecht, the Netherlands 3 Department of Gastroenterology and Hepatology, St Antonius Hospital, Nieuwegein, the Netherlands 4 Department of Clinical Epidemiology and Biostatistics, Academic Medical Center, Amsterdam, the Netherlands ABSTRACT 5 Department of Surgery, Academic Medical Center, Background and study aims Sealing esophageal leaks by Amsterdam, the Netherlands stent placement allows healing in 44%– 94% of patients. 6 Department of Gastroenterology and Hepatology, Weaimedtodevelopapredictionruletopredictthechance Erasmus University Medical Center, Rotterdam, the of successful stent therapy. Netherlands Patients and methods In this multicenter retrospective cohort study, patients with benign upper gastrointestinal submitted 26.4.2017 leakage treated with stent placement were included. We accepted after revision 26.7.2017 used logistic regression analysis including four known clini- cal predictors of stent therapy outcome. The model per- Bibliography formance to predict successful stent therapy was evaluated DOI https://doi.org/10.1055/s-0043-118591 in an independent validation sample. Published online: 21.9.2017 | Endoscopy 2018; 50: 98–108 Results We included etiology, location, C-reactive protein, © Georg Thieme Verlag KG Stuttgart · New York and size of the leak as clinical predictors. The model was es- ISSN 0013-726X timated from 145 patients (derivation sample), and 59 pa- tients were included in the validation sample. Stent therapy Corresponding author was successful in 55.9% and 67.8% of cases, respectively. Jeanin E. van Hooft, MD, PhD, Department of The predicted probability of successful stent therapy was Gastroenterology and Hepatology, Room C2-115, Downloaded by: University of Utrecht. Copyrighted material. significantly higher in success patients compared with fail- Academic Medical Center, Meibergdreef 9, 1105 AZ ure patients in both the derivation (P <0.001) and validation Amsterdam, The Netherlands (P <0.001) samples. The area under the receiver operating Fax: +31-20-6917033 characteristic curve was 74.1% in the derivation sample [email protected] and 84.7% in the validation sample. When the model pre- dicted ≥ 70% chance of success, the positive predictive val- Supplementary material ue was 79% in the derivation sample and 87% in the valida- Online content viewable at: tion sample. When the model predicted≤ 50% chance of https://doi.org/10.1055/s-0043-118591 success, the negative predictive value was 64% and 86%, respectively. Conclusions This prediction rule, consisting of four clinical predictors, could identify patients with esophageal leaks who were likely to benefit from or fail on stent therapy. The prediction rule can support clinical decision-making when the predicted probability of success is≥ 70 % or ≤ 50%. 98 van Halsema Emo E et al. Stent placement for… Endoscopy 2018; 50: 98–108 A leak or perforation was diagnosed based on the combina- Introduction tion of clinical signs and radiological or endoscopic evidence of Anastomotic leaks after esophagectomy cause severe morbid- a transmural esophageal defect. Symptomatology included at ity, prolongation of hospitalization, intensive care unit (ICU) ad- least one of the following symptoms: severe cervical or thoracic mission, and even mortality [1– 5]. Leakage develops in 6% – pain, subcutaneous emphysema, elevated C-reactive protein 24% of patients undergoing esophageal surgery with esopha- (CRP) level or leukocyte count, sepsis, air leakage through the gogastrostomy [2,6– 13], and leads to increased postoperative drain or wound, and/or excessive drain or wound production. mortality rates of 7.2%– 18.2% compared with 3.1% – 6.2% in Radiological evidence included leakage of oral contrast outside patients without leakage [1– 3]. The aim of treatment of the esophagus at computed tomography (CT) scan or esopha- esophageal leaks is to prevent sepsis and allow healing by ad- gogram. A fistula was defined as a radiologically or endoscopi- ministration of antibiotics, bypassing the esophageal defect cally proven connection between the esophagus and the re- with a duodenal feeding tube, and adequate drainage of infec- spiratory tract, the cutis or the pleura. Perforations included all ted fluid collections. iatrogenic and spontaneous transmural esophageal lacerations. Another way to prevent further contamination of the para- The primary outcome of the study was successful leakage esophageal cavity is by sealing off the defect with an esopha- control after esophageal stent placement. We defined success geal stent [14]. Endoscopic stent placement for esophageal as no need for additional invasive procedures (surgery or percu- leaks and perforations allows complete healing in approximate- taneous drainage) after stent removal without persisting symp- ly 80% of cases in pooled literature analyses [14,15]. Either fully toms of leakage, or as successful sealing without further symp- covered or partially covered self-expandable stents are used for toms of leakage in case it was decided that the stent was left in sealing esophageal disruptions. The pitfall of esophageal stent permanently. Follow-up was calculated as the time between the placement is the high risk of stent migration, which occurs in first stent placement procedure and the date of last contact. 11%– 27% of cases, depending on the type of stent [14,15]. In- adequate sealing may be one of the reasons why the clinical Procedures success rates of esophageal stent placement vary widely from Because of the retrospective study design, procedures were not 44% to 94% [15]. Optimal drainage of adjacent fluid collections standardized. In general, when an upper gastrointestinal leak is also essential for the success of stent therapy. Other factors was suspected, imaging studies (CT scan or esophagogram) that contribute to successful stent therapy are the size of the and/or endoscopy were performed to confirm the diagnosis. In defect, the etiology of the leak, the severity of sepsis, and the case of a suspected cervical anastomotic leak, the neck wound delay between diagnosis and stent insertion [16– 20]. was re-opened for exploration and drainage. Patients received Leakage control is crucial for the healing process in these se- antibiotics and were kept on a “nil by mouth” regimen with verely ill patients. If we were able to predict the success of stent duodenal tube feeding or feeding jejunostomy. Infected fluid therapy, we could select patients who are likely to benefit from collections were drained by radiological tube placement when- stent placement. In this way, patients in whom stent therapy is ever possible. likely to fail can be identified and treated differently. Therefore, The treating surgeon and gastroenterologist determined the aim of the current study was to evaluate the performance of whether stent placement was indicated. Proximal stent place- a clinical prediction rule to predict the chance of successful ment across the upper esophageal sphincter was considered a stent therapy in the treatment of benign upper gastrointestinal contraindication for stent placement. Stent placement was per- Downloaded by: University of Utrecht. Copyrighted material. leaks. formed endoscopically at the endoscopy ward with or without fluoroscopic guidance. In case of ICU admission, endoscopic stent placement took place at the ICU without the support of Patients and methods fluoroscopy. Anesthesia during the procedure consisted of This study was designed as a multicenter retrospective cohort monitored anesthesia care using propofol or conscious seda- study including three tertiary care university hospitals and one tion using midazolam and/or fentanyl. Either fully covered or general teaching hospital from the Netherlands. The study was partially covered self-expandable metal stents (SEMSs) were reviewed by the Medical Ethics Review Committee of the Aca- used, which were preferably removed after 4– 6weeks.Stents demic Medical Center and did not apply to the Dutch Act “Med- were removed by pulling either the proximal end or distal end ical Research Involving Human Subjects” (date of review: 17 (inside-out) of the stent with a grasping forceps. The stent-in- June 2015). stent technique was used for the removal of embedded partial- We electronically searched the endoscopic database ENDO- ly covered SEMSs [21]. BASE (Olympus Medical Systems, Hamburg, Germany) and a The aim of stent therapy was to achieve leakage control, de- prospectively collected database of all esophagectomy patients fined as a stable clinical condition, allowing oral intake and to identify suitable candidates for inclusion. All patients who re- healing of the defect. When stent dysfunction and persistent ceived an esophageal stent for the treatment of benign anasto- leakage was suspected, endoscopy was performed. In case of motic leakage, perforation or fistula were included. Patients stent migration or inadequate sealing, stents were either repo- with active malignant esophageal
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