EUS-GE vs ES for Palliation of Gastric Outlet Obstruction

Gastric Outlet Obstruction Clinical Trial

Official title:

EUS-guided Gastroenterostomy Versus Enteral Stenting for Palliation of Malignant Gastric Outlet Obstruction: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03259763
• Other study ID #: IRB00128878
• Status: Recruiting
• Phase: N/A
• Start date: October 26, 2020
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: Johns Hopkins University
• Contact: Mouen A. Khashab, MD
• Phone: 443-509-3388
• Email: mkhasha1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Gastric Outlet Obstruction
• Pyloric Stenosis

Intervention

Device:
• Lumen-apposing metal stent
In this technique, the gastric wall and its adjacent small intestine are punctured by a needle to make a connection between the stomach and small intestine. Then a lumen-apposing metal stent is deployed at the puncture site to keep the stomach-small intestine connection open.
• Self-expandable metal stent
In this technique, under endoscopic visualization, a guidewire will be advanced through the obstructed part of the stomach. Then an enteral self-expandable metal stent will be deployed under direct endoscopic visualization and fluoroscopic guidance.

Locations

Country	Name	City	State
Canada	The Research Institute of McGill University Health Centre	Montréal	Quebec
Ecuador	Ecuadorian Institute of Digestive Diseases (IECED)	Guayaquil
France	Limoges University Hospital	Limoges
France	Hospital Prive des Peupliers	Paris
India	Asian Institute of Gastroenterology	Hyderabad
Israel	Emek Medical Center	Afula
Spain	Hospital Universitario Rio Hortega	Valladolid
United States	The Johns Hopkins Hospital	Baltimore	Maryland
United States	Brigham & Women's Hospital - Harvard	Boston	Massachusetts
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Yale University	New Haven	Connecticut
United States	Cuimc/Nyph	New York	New York
United States	NYU Langone Health	New York	New York
United States	Wake Forest Baptist University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Canada,  Ecuador,  France,  India,  Israel,  Spain, 

References & Publications (9)

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. — View 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. Erratum In: Surg Endosc. 2017 Jul 17;: — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of gastric outlet obstruction recurrence	Recurrence of nausea, vomiting, and inability to tolerate PO intake up to 3 months after the procedure confirmed either endoscopically and/or radiographically.	3 months
Secondary	Technical success rate	Adequate positioning and deployment of the stent(s) as determined endoscopically and radiographically.	Day of procedure
Secondary	Clinical success rate	The improvement of at least 1 point in the gastric outlet obstruction score within 7 days after stent insertion.	1 week
Secondary	Length of procedure		Day of procedure
Secondary	Adverse events rate		1 week
Secondary	Post-procedure length of hospital stay		1 week
Secondary	Reintervention rate for recurrent gastric outlet obstruction		3 months
Secondary	Quality of Life SF-36 questionnaire scoring	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.	3 months
Secondary	Overall survival rate		1 year
Secondary	Time to recurrent gastric outlet obstruction		3 months
Secondary	Gastric Outlet Obstruction Scoring system (GOOSS)	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 = no oral intake, 1 = liquids only, 2 = soft solids, 3 = low-residue or full diet	1 year
Secondary	Stent Dysfunction Rate	the restenosis of the stent due to tumor ingrowth or overgrowth, stent migration, or fracture	3 months
Secondary	Duration of stent patency	Calculated from the time of stent placement to the time of stent dysfunction	3 months