Cricopharyngeal Dysfunction and Esophageal Diverticulum

Overview

About this study

Patients undergoing open transcervical or endoscopic approach in which a laser or stapler is used to divide the common wall between the diverticulum and esophagus, or who are not surgical candidates but agree to follow-up.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria:

  • Patients with a diagnosis of cervical esophageal diverticulum, with Zenker's as most common, or CP bar (with diagnosis of early Zenker) as indicated on an esophagram who the participating institutions enroll regardless of surgical management and future treatments.
  • Patients undergoing open transcervical or endoscopic approach in which a laser or stapler is used to divide the common wall between the diverticulum and esophagus, or who are not surgical candidates but agree to follow-up.

Exclusion Criteria:

  • Patients who undergo division of the common wall between the diverticulum and esophagus using flexible endoscopy will not be included in the study.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Dale Ekbom, M.D.

Open for enrollment

Contact information:

Marissa Larson

(507) 216-4999

Larson.Marissa@mayo.edu

More information

Publications

  • Endoscopic Zenker diverticulotomy (EZD) is a primary treatment for Zenker diverticulum (ZD). During EZD, the diverticulum is not excised, and interpretation of postoperative videofluoroscopic swallow study (VFSS) is challenging. The purpose of this investigation was to describe normal VFSS findings status post-successful EZD. Read More on PubMed
  • This study was designed to compare rates of failure, revision and morbidity from endoscopic and open approaches as treatment for pharyngeal pouch. Systematic review was conducted using MEDLINE and PubMed databases. Search terms treatment, Zenker's, hypopharyngeal, pharyngeal, diverticulum, and pouch. There were no randomised clinical trials. Therefore, cohort and comparative studies with at least 10 patients in each arm, a follow-up of a least 12 months and reporting on all patients were included. Seventy-one studies met inclusion criteria. Diverticulectomy with or without cricopharyngeal myotomy comprised 33 studies (1,990 patients), and endoscopic stapler diverticulotomy was in 22 studies (1,089 patients). Failure of open and endoscopic approaches was 4.2 and 18.4%, respectively, and corresponding complication rates were 11 and 7%. Within endoscopic techniques, failure rates were 18.9% for stapler diverticulotomy and 21.7% for laser diverticulotomy. Corresponding complication rates were 4.3 and 7.9%. Flexible endoscopy techniques have a higher failure (29%) and overall complication rate (14.3%). Most reported complications for transcervical techniques relate to the recurrent nerve (3.4%) and salivary fistula (3.7%) and for endoscopic group emphysema (3.0%) and mediastinitis (1.2%). Operation-related deaths were infrequent in both groups, but more frequent with open approach (0.9 vs. 0.4%). Open approaches have more success but more complications than endoscopic techniques. Taking in account overall complications and failure rates, open approaches and stapler diverticulotomy yield different patterns, but are arguably comparable. In younger patients open approach is preferred, as well in patients with unfavourable anatomic conditions for endoscopic exposure. Flexible endoscopic techniques provide a suitable option for patients who do not tolerate general anaesthesia. Read More on PubMed
  • Surgical treatment of Zenker's diverticulum (ZD) has evolved over the previous 2 decades to a predominantly endoscopic approach. In this study, we review our experience with endoscopic staple-assisted diverticulostomy (ESD) for treatment of ZD from 2002 to 2011. Read More on PubMed
  • To evaluate outcomes following endoscopic management of Zenker's diverticula using a carbon dioxide laser (CO2) or stapler-assisted technique, a systematic review and meta-analysis were conducted. Seven retrospective, uncontrolled case series including 391 procedures met selection criteria. No higher quality studies were identified. Outcomes favoring the stapler technique included a shorter duration of nil per os (NPO) status (2 studies), length of hospitalization (LOH, 2 studies), and fewer postoperative fevers and abnormal chest x-rays (1 study). Outcomes favoring the CO2 technique included greater improvement in postoperative dysphagia and regurgitation scores (2 studies) and a lower revision rate (1 study). Meta-analysis demonstrated increased nondental complications in the CO2 group (odds ratio 3.81; 95% confidence interval, 1.37-10.59; P = .01) but no difference in duration of NPO (P = .06), LOH (P = .07), overall complications (P = .08), dental complications (P = .57), major complications (P = .38), or revision surgery (P = .82). Implications are limited by the quality of studies identified. Read More on PubMed
  • Endoscopic stapling of Zenker's diverticulum (ZD) is now established practice in the UK and is routinely performed by the vast majority of otolaryngologists. Both The National Confidential Enquiry into Peri-Operative Deaths and the National Institute for Health and Clinical Excellence recommended that the procedure be undertaken at specialist centres and that each department should audit their respective outcomes. Despite the abundance of review articles, it remains unclear what variables a meaningful audit is required to collate and what gold standards every department in the UK undertaking surgery for ZD should aspire to achieve. The objective was to review the outcomes of endoscopic stapling of Zenker's diverticulum at this institution. In addition, a review of other UK departments was undertaken to formulate minimum clinical standards and recommendations of best practice. Review of patient case notes and a structured search of PubMed were used as materials. Fifteen retrospective case series were identified from the literature search which fulfilled the inclusion criteria. Fifty-one patients were identified from the present audit. When these were added to the review, a total of 585 patients were available for meta-analysis. 540 (92.3%) were successfully stapled. Forty-five (7.7%) procedures were abandoned intra-operatively. The most common reason was difficulty assessing the small pouch. The majority of patients (92%) had resumed oral intake by the second post-operative day. Most patients (87%) were discharged by the second post-operative day. Outcomes were good with over 90% reporting resolved or significantly improved symptoms. Minor complications included dental trauma, transient hoarseness and sore throat causing delayed resumption of oral intake. The overall perforation rate was 4.8%. One death was reported. In conclusion endoscopic stapling of pharyngeal pouch is a safe procedure that is associated with good outcomes and low complication rates. No death has been reported since 2000 in the UK. The data presented in this review represent current clinical standards reported over the past 15 years by UK departments and serve as a useful benchmark for any future audits undertaken. Read More on PubMed
  • Zenker's diverticulum (ZD) is a common source of dysphagia with a well-established surgical treatment history. Variations may exist between practitioners in the preoperative, intraoperative, and postoperative management of patients with ZD because of recent evolutions in surgical approach toward an endoscopic technique. Read More on PubMed
  • The Eating Assessment Tool is a self-administered, symptom-specific outcome instrument for dysphagia. The purpose of this study was to assess the validity and reliability of the 10-item Eating Assessment Tool (EAT-10). Read More on PubMed
  • Laryngopharyngeal reflux (LPR) is present in up to 50% of patients with voice disorders. Currently, there is no validated instrument that documents symptom severity in LPR. We developed the reflux symptom index (RSI), a self-administered nine-item outcomes instrument for LPR. The purpose of this investigation was to evaluate the psychometric properties of the RSI. For validity assessment, 25 patients with LPR were evaluated prospectively before and six months after b.i.d. treatment with proton pump inhibitors (PPI). Each patient completed the RSI as well as the 30-item voice handicap index (VHI). For reliability assessment, the study patients were given the RSI on two separate occasions before the initiation of treatment. Normative RSI data were derived from 25 age-matched and gender-matched controls taken from an existing database of asymptomatic individuals without any evidence of LPR. The mean RSI (+/- standard deviation) of patients with LPR improved from 21.2 (+/- 10.7) to 12.8 (+/- 10.0), and the mean VHI improved from 52.2 (+/- 24.7) to 41.5 (+/- 25.0) after 6 months of therapy (p = 0.001 and 0.065, respectively). Of the three VHI subscales (emotional, physical, functional), only the functional subscale improved significantly (p = 0.037). Patients who experienced a five point or better improvement in RSI were 11 times more likely to experience a five-point improvement in VHI (95% confidence interval = 1.7, 76.8). For reliability assessment, the first and second pretreatment RSIs were 19.9 (+/- 11.1) and 20.9 (+/- 9.6), respectively (correlation coefficient = 0.81, p < 0.001). The single-item correlation coefficients ranged from 0.41 to 0.91 (p < 0.05 for all items). The mean pretreatment RSI in patients with LPR was significantly higher than controls (21.2 versus 11.6; p < 0.001). The mean RSI of patients with LPR after 6 months of PPI therapy approached that of asymptomatic controls (p > 0.05). The RSI is easily administered, highly reproducible, and exhibits excellent construct and criterion-based validity. Read More on PubMed

Study Results Summary

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Supplemental Study Information

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CLS-20363740

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