Clinical trial NCT03259763: EUS-GE vs ES for Palliation of Gastric Outlet Obstruction
Official title: EUS-guided Gastroenterostomy Versus Enteral Stenting for Palliation of Malignant Gastric Outlet Obstruction: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gastric Outlet Obstruction
Keywords: Gastroenterostomy
Gastric Outlet Obstruction
Cancer
Endosonography
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2017-08-24
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly allocated with a 1:1 ratio to one of the study arms (EUS-GE or ES)
Primary purpose: TREATMENT

Brief summary: Gastric outlet obstruction (GOO) is a common complication of luminal malignancies which is associated with substantial morbidity. Palliation of GOO has traditionally been through the surgical bypass of the obstructed lumen by creating an opening between the stomach and small intestine. However, In recent years, a less invasive approach, i.e. endoscopic stenting, has gained wide acceptance to treat unresectable malignant gastric outlet obstruction. In this study, the investigators are going to compare the safety and efficacy of the two different endoscopic techniques including Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) and enteral stenting (ES).

Detailed description: 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.

Eligibility criteria: Inclusion 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 18-80 years

Exclusion 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
* Life expectancy of less than 3 months based on the endoscopist's opinion
* 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 \> 1.5 or platelet \< 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
* One of the two techniques (EUS-GE and ES) cannot be performed (at the discretion of the endoscopist)

Primary outcomes:
measure: Rate of gastric outlet obstruction recurrence
timeFrame: 3 months
Secondary outcomes:
measure: Technical success rate
timeFrame: Day of procedure
measure: Clinical success rate
timeFrame: 1 week
measure: Length of procedure
timeFrame: Day of procedure
measure: Adverse events rate
timeFrame: 1 week
measure: Post-procedure length of hospital stay
timeFrame: 1 week
measure: Reintervention rate for recurrent gastric outlet obstruction
timeFrame: 3 months
measure: Quality of Life SF-36 questionnaire scoring
timeFrame: 3 months
measure: Overall survival rate
timeFrame: 1 year
measure: Time to recurrent gastric outlet obstruction
timeFrame: 3 months
measure: Gastric Outlet Obstruction Scoring system (GOOSS)
timeFrame: 1 year
measure: Stent Dysfunction Rate
timeFrame: 3 months
measure: Duration of stent patency
timeFrame: 3 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
city: Winston-Salem
country: United States
facility: Wake Forest Baptist University
state: North Carolina
city: Montréal
country: Canada
facility: The Research Institute of McGill University Health Centre
state: Quebec
city: Guayaquil
country: Ecuador
facility: Ecuadorian Institute of Digestive Diseases (IECED)
city: Paris
country: France
facility: Hospital Prive des Peupliers
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology
city: Afula
country: Israel
facility: Emek Medical Center
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega
Study officials:
affiliation: Johns Hopkins University
name: Mouen A. Khashab, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mittal A, Windsor J, Woodfield J, Casey P, Lane M. Matched study of three methods for palliation of malignant pyloroduodenal obstruction. Br J Surg. 2004 Feb;91(2):205-9. doi: 10.1002/bjs.4396.
citation: Johnsson E, Thune A, Liedman B. Palliation of malignant gastroduodenal obstruction with open surgical bypass or endoscopic stenting: clinical outcome and health economic evaluation. World J Surg. 2004 Aug;28(8):812-7. doi: 10.1007/s00268-004-7329-0. Epub 2004 Aug 3.
citation: Maetani I, Akatsuka S, Ikeda M, Tada T, Ukita T, Nakamura Y, Nagao J, Sakai Y. Self-expandable metallic stent placement for palliation in gastric outlet obstructions caused by gastric cancer: a comparison with surgical gastrojejunostomy. J Gastroenterol. 2005 Oct;40(10):932-7. doi: 10.1007/s00535-005-1651-7.
citation: Khashab M, Alawad AS, Shin EJ, Kim K, Bourdel N, Singh VK, Lennon AM, Hutfless S, Sharaiha RZ, Amateau S, Okolo PI, Makary MA, Wolfgang C, Canto MI, Kalloo AN. Enteral stenting versus gastrojejunostomy for palliation of malignant gastric outlet obstruction. Surg Endosc. 2013 Jun;27(6):2068-75. doi: 10.1007/s00464-012-2712-7. Epub 2013 Jan 9.
citation: Khashab MA, Kumbhari V, Grimm IS, Ngamruengphong S, Aguila G, El Zein M, Kalloo AN, Baron TH. EUS-guided gastroenterostomy: the first U.S. clinical experience (with video). Gastrointest Endosc. 2015 Nov;82(5):932-8. doi: 10.1016/j.gie.2015.06.017. Epub 2015 Jul 26.
citation: Itoi T, Baron TH, Khashab MA, Tsuchiya T, Irani S, Dhir V, Bun Teoh AY. Technical review of endoscopic ultrasonography-guided gastroenterostomy in 2017. Dig Endosc. 2017 May;29(4):495-502. doi: 10.1111/den.12794. Epub 2017 Jan 27.
citation: Chen YI, Itoi T, Baron TH, Nieto J, Haito-Chavez Y, Grimm IS, Ismail A, Ngamruengphong S, Bukhari M, Hajiyeva G, Alawad AS, Kumbhari V, Khashab MA. EUS-guided gastroenterostomy is comparable to enteral stenting with fewer re-interventions in malignant gastric outlet obstruction. Surg Endosc. 2017 Jul;31(7):2946-2952. doi: 10.1007/s00464-016-5311-1. Epub 2016 Nov 10.
citation: Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.
citation: Adler DG, Baron TH. Endoscopic palliation of malignant gastric outlet obstruction using self-expanding metal stents: experience in 36 patients. Am J Gastroenterol. 2002 Jan;97(1):72-8. doi: 10.1111/j.1572-0241.2002.05423.x.