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Title:
EUS-guided gastroenterostomy versus enteral stenting for palliation of malignant gastric outlet obstruction: a randomized clinical trial
Protocol Number:
J17126
Phase:
NULL
Physician:
Mouen Khashab
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
Primary Outcome Measures: •Recurrent gastric outlet obstruction rate [ Time Frame: 1 year ]Recurrence of nausea, vomiting, and inability to tolerate PO intake greater than 2 weeks after the procedure confirmed either endoscopically and/or radiographically. The need for unplanned re-intervention (endoscopic or surgical) to treat recurrent GOO will also be considered a surrogate for recurrent GOO. Secondary Outcome Measures: •Technical success rate [ Time Frame: Day of procedure ]Adequate positioning and deployment of the stent(s) as determined endoscopically and radiographically.•Clinical success rate [ Time Frame: Day of procedure ]The ability to tolerate at least a full liquid diet without vomiting•Length of procedure [ Time Frame: Day of procedure ]•Adverse events rate [ Time Frame: 1 week ]•Post-procedure length of hospital stay [ Time Frame: 1 week ]•Reintervention rate for recurrent gastric outlet obstruction [ Time Frame: 1 year ]•Quality of Life SF-36 questionnaire scoring [ Time Frame: 1 month ]The SF-36 general health questionnaire consists of 36 questions evaluating the patient's perception of their quality of life (QoL) in the following eight subscales: physical functioning (PF), role limitations due to physical problems (RP), role limitations due to emotional problems (RE), energy/fatigue (EF), emotional well-being (EW), social functioning (SF), bodily pain (BP) and general health (GH). Subscale scores range from 0 to 100, with 100 being the best and 0 being the worst quality of life.•Overall survival rate [ Time Frame: 1 year ]•Time to recurrent gastric outlet obstruction [ Time Frame: 1 year ]•Gastric Outlet Obstruction Scoring system (GOOSS) [ Time Frame: 1 year ]Diet toleration will be scored based on the Gastric Outlet Obstruction Scoring System (GOOSS). The scoring ranges from 0 to 3 in the following format:0 equal to no oral intake, 1 equal to liquids only, 2 equal to soft solids, 3 equal to low-residue or full dietEstimated Enrollment: 96 Anticipated Study Start Date: October 2017 Estimated Study Completion Date: October 2019 Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Eligibility:
Ages Eligible for Study: 18 Years and older (Adult, Senior) Sexes Eligible for Study: All Accepts Healthy Volunteers: No CriteriaInclusion Criteria:•Adult patients with malignant, symptomatic gastric outlet obstruction due to an unresectable malignant lesion•Gastric outlet obstruction scoring system (GOOSS) score of 0 (no oral intake) or 1 (liquids only)•Age greater than equal to 18Exclusion Criteria:•Evidence of other strictures in the gastrointestinal (GI) tract•Previous gastric, periampullary or duodenal surgery•World Health Organization (WHO) performance score of 4 (patient is 100% of time in bed)•Unable to fill out quality of life questionnaire•Unable to sign the informed consent•Cancer extending into the body of the stomach, 4th portion of the duodenum or proximal jejunum around the ligament of Treitz•Large volume ascites•Inability to tolerate sedated upper endoscopy due to cardiopulmonary instability, severe pulmonary disease or other severe comorbidities•Pregnant or breastfeeding women•Uncorrectable coagulopathy defined by INR greater than 1.5 or platelet less than 50000/µl•Complete GOO evidenced by inability to either pass a wire across the stricture and/or inability to opacify small bowel distal to the malignant stricture•Resectable or borderline resectable tumors
Treatment:
In recent years, Enteral Stenting (ES) has commonly been used as the first line management of unresectable malignant gastric outlet obstruction. On the other hand, Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) is the most recently described technique for palliation of malignant GOO, which has the theoretical potential to minimize the risk for stent occlusion while maintaining the less invasive endoscopic approach. This novel endoscopic treatment entails creating a gastroenterostomy under EUS-guidance thereby bypassing the occluded lumen. This endoscopic technique has been performed to treat patients with GOO since 2014, and recent retrospective studies have shown that EUS-GE was comparable to ES in terms of efficacy and safety; however, EUS-GE was associated with a significantly decreased risk of recurrent GOO and reinterventions.Based on the investigator's clinical experience for the last three years and the above-mentioned study results, the goal of this study is to prospectively compare EUS-GE with ES in the management of unresectable malignant gastric outlet obstruction. The investigators hypothesize that EUS-GE is associated with comparable technical and clinical success and safety profile while requiring fewer re-interventions.
Population:
Adult
Last Update
08/11/2020 05:02 AM