Endoscopic Ultrasound-Guided Gastroenterostomy for Malignant Gastric Outlet Obstruction

Malignant Gastric Outlet Obstruction Clinical Trial

Official title:

Safety and Efficacy of Endoscopic Ultrasound-Guided Gastroenterostomy for the Treatment of Malignant Gastric Outlet Obstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04810377
• Other study ID #: R-2020-3601-298
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: July 2022
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: Oscar V Hernández Mondragón, MD
• Phone: +525556276900
• Email: mondragonmd[@]yahoo.co.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Malignant gastric outlet obstruction is a very disabling complication of patients with gastric, duodenal, ampullary, pancreatic, or bile duct cancer and worsens their prognosis. Current treatments have reported a similar complication rate and higher mortality in surgically treated patients. Recently, the creation of endoscopic ultrasound-guided gastroenterostomy (EUS) has shown promising results in these patients. The aim of this research is to determine the safety and efficacy of EUS-guided gastro-enterostomy in the treatment of patients with malignant gastric outlet obstruction.

Description:

Malignant gastric outlet obstruction is a very disabling complication that occurs in 15% to 25% of patients with gastric, duodenal, ampullary, pancreatic, or bile duct cancer and worsens their prognosis. Roux-en-Y gastrojejunostomy is considered the gold standard treatment with technical success of 98.6% (97-3% -99.9%) and clinical success of 80.1% with patency of 169.2 (136.8-201.7) days. On the other hand, the technical success reported for self-expanding metal stents is 96.2% (94.1% vs. 98.4%), technical success is 79.4%, and patency at 6 months was only 57%. However, complications occur in a similar way in both forms of treatment (major complications in 6% and late complications in 17% in both, but mortality is higher in the group treated with Roux-en-Y gastrojejunostomy (29% vs. 17%). , p <0.001) Recently, the creation of endoscopic ultrasound-guided gastroenterostomy has shown success rates of over 90% in case series, but prospective studies evaluating the safety and efficacy of the procedure are lacking. The aim of this research to determine the safety and efficacy of EUS-guided gastro-enterostomy in the treatment of patients with malignant gastric outlet obstruction.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients of both genders over 18 years of age with gastric outlet obstruction syndrome secondary to stage III or more at gastric, duodenal or pancreatic cancer who are candidates for palliative treatment, who do not want surgical treatment.
• Diagnosis confirmed as follows:
• Histopathological report of cancer.
• Simple and contrasted thoracoabdominal tomography.
• Tolerance to oral feeding based on liquids only or null.

Exclusion Criteria:

• Patients who do not accept the signing of the informed consent.
• Postoperative patients with Roux-en-Y gastrojejunostomy.
• Patients with large volume ascites.
• Patients with malignant obstruction distal to the jejunal puncture.
• Pregnant women.
• Patients with a Karnofsky index less than 50 or an E.C.O.G. greater than or equal to 4 points.
• Patients in whom any endoscopic procedure has been contraindicated for any reason.
• Patients who want to undergo surgical treatment as an initial option.
• Patients with malignant biliary obstruction without endoscopic treatment at the time of gastric outflow tract obstruction presentation.

Elimination Criteria:

• Patients who undergo the endoscopic procedure but cannot be completed due to transmural invasion of malignancy, hemorrhage or inability to puncture the intestinal loop with any method described, puncture site> 2cm away from the gastric wall or inability to pass the guidewire through obstruction (unless direct technique is performed).
• Patients who do not attend follow-up.

Related Conditions & MeSH terms

• Gastric Outlet Obstruction
• Malignant Gastric Outlet Obstruction
• Pyloric Stenosis

Intervention

Procedure:
• EUS-guided gastroenterostomy
First after an upper endoscopy is performed, a catheters passed throughout the endoscope channel and with x-ray verification, a guide wire is passed up to the third portion of duodenal loop. then small intestinal is filled with saline solution up to 1500cc and contrast solution. Then an endoscopic ultrasound examination will be carried out where a loop of the small intestine that is located less than 2 cm apart from the gastric wall will be looked for. Once the intestinal loop is identified a direct antegrade puncture will be performed with a luminal apposition prosthesis release system . Finally, correct position is verified with x-ray and we will look for any misplacement or leakage during this process or the presence of bleeding. Endoscopic treatment will be performed if necessary. Subsequently, the participants will go to monthly follow-up with clinical evaluation, laboratory and radiological test will be carried out until the participants dies.

Locations

Country	Name	City	State
Mexico	Centro Medico Nacional Siglo XXI Hospital de Especialidades	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (40)

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. — View Citation

Amin S, Sethi A. Endoscopic Ultrasound-Guided Gastrojejunostomy. Gastrointest Endosc Clin N Am. 2017 Oct;27(4):707-713. doi: 10.1016/j.giec.2017.06.009. Review. — View Citation

Balderramo DC. [Gastric outlet obstruction]. Rev Esp Enferm Dig. 2008 Feb;100(2):98-9. Spanish. — View Citation

Barthet M, Binmoeller KF, Vanbiervliet G, Gonzalez JM, Baron TH, Berdah S. Natural orifice transluminal endoscopic surgery gastroenterostomy with a biflanged lumen-apposing stent: first clinical experience (with videos). Gastrointest Endosc. 2015 Jan;81(1):215-8. doi: 10.1016/j.gie.2014.09.039. — View Citation

Binmoeller KF, Shah JN. Endoscopic ultrasound-guided gastroenterostomy using novel tools designed for transluminal therapy: a porcine study. Endoscopy. 2012 May;44(5):499-503. doi: 10.1055/s-0032-1309382. Epub 2012 Apr 24. — View Citation

Chandrasegaram MD, Eslick GD, Mansfield CO, Liem H, Richardson M, Ahmed S, Cox MR. Endoscopic stenting versus operative gastrojejunostomy for malignant gastric outlet obstruction. Surg Endosc. 2012 Feb;26(2):323-9. doi: 10.1007/s00464-011-1870-3. Epub 2011 Sep 5. — View Citation

Dormann A, Meisner S, Verin N, Wenk Lang A. Self-expanding metal stents for gastroduodenal malignancies: systematic review of their clinical effectiveness. Endoscopy. 2004 Jun;36(6):543-50. Review. — View Citation

Espinel J, Vivas S, Muñoz F, Jorquera F, Olcoz JL. Palliative treatment of malignant obstruction of gastric outlet using an endoscopically placed enteral Wallstent. Dig Dis Sci. 2001 Nov;46(11):2322-4. — View Citation

Fan W, Tan S, Wang J, Wang C, Xu H, Zhang L, Liu L, Fan Z, Tang X. Clinical outcomes of endoscopic ultrasound-guided gastroenterostomy for gastric outlet obstruction: a systematic review and meta-analysis. Minim Invasive Ther Allied Technol. 2022 Feb;31(2):159-167. doi: 10.1080/13645706.2020.1792500. Epub 2020 Jul 16. — View Citation

Fritscher-Ravens A, Mosse CA, Mills TN, Mukherjee D, Park PO, Swain P. A through-the-scope device for suturing and tissue approximation under EUS control. Gastrointest Endosc. 2002 Nov;56(5):737-42. — View Citation

Fritscher-Ravens A, Mosse CA, Mukherjee D, Mills T, Park PO, Swain CP. Transluminal endosurgery: single lumen access anastomotic device for flexible endoscopy. Gastrointest Endosc. 2003 Oct;58(4):585-91. Review. — View Citation

Ge PS, Young JY, Dong W, Thompson CC. EUS-guided gastroenterostomy versus enteral stent placement for palliation of malignant gastric outlet obstruction. Surg Endosc. 2019 Oct;33(10):3404-3411. doi: 10.1007/s00464-018-06636-3. Epub 2019 Feb 6. — View Citation

Hori Y, Naitoh I, Hayashi K, Ban T, Natsume M, Okumura F, Nakazawa T, Takada H, Hirano A, Jinno N, Togawa S, Ando T, Kataoka H, Joh T. Predictors of outcomes in patients undergoing covered and uncovered self-expandable metal stent placement for malignant gastric outlet obstruction: a multicenter study. Gastrointest Endosc. 2017 Feb;85(2):340-348.e1. doi: 10.1016/j.gie.2016.07.048. Epub 2016 Jul 27. — View Citation

Irani S, Baron TH, Itoi T, Khashab MA. Endoscopic gastroenterostomy: techniques and review. Curr Opin Gastroenterol. 2017 Sep;33(5):320-329. doi: 10.1097/MOG.0000000000000389. Review. — View Citation

Itoi T, Ishii K, Ikeuchi N, Sofuni A, Gotoda T, Moriyasu F, Dhir V, Teoh AY, Binmoeller KF. Prospective evaluation of endoscopic ultrasonography-guided double-balloon-occluded gastrojejunostomy bypass (EPASS) for malignant gastric outlet obstruction. Gut. 2016 Feb;65(2):193-5. doi: 10.1136/gutjnl-2015-310348. Epub 2015 Aug 17. — View Citation

Itoi T, Ishii K, Tanaka R, Umeda J, Tonozuka R. Current status and perspective of endoscopic ultrasonography-guided gastrojejunostomy: endoscopic ultrasonography-guided double-balloon-occluded gastrojejunostomy (with videos). J Hepatobiliary Pancreat Sci. 2015 Jan;22(1):3-11. doi: 10.1002/jhbp.148. Epub 2014 Aug 24. Review. — View Citation

Itoi T, Itokawa F, Uraoka T, Gotoda T, Horii J, Goto O, Moriyasu F, Moon JH, Kitagawa Y, Yahagi N. Novel EUS-guided gastrojejunostomy technique using a new double-balloon enteric tube and lumen-apposing metal stent (with videos). Gastrointest Endosc. 2013 Dec;78(6):934-939. doi: 10.1016/j.gie.2013.09.025. — View Citation

Jang JK, Song HY, Kim JH, Song M, Park JH, Kim EY. Tumor overgrowth after expandable metallic stent placement: experience in 583 patients with malignant gastroduodenal obstruction. AJR Am J Roentgenol. 2011 Jun;196(6):W831-6. doi: 10.2214/AJR.10.5861. — View Citation

Jang S, Stevens T, Lopez R, Bhatt A, Vargo JJ. Superiority of Gastrojejunostomy Over Endoscopic Stenting for Palliation of Malignant Gastric Outlet Obstruction. Clin Gastroenterol Hepatol. 2019 Jun;17(7):1295-1302.e1. doi: 10.1016/j.cgh.2018.10.042. Epub 2018 Oct 31. — View Citation

Jeong SJ, Lee J. Management of gastric outlet obstruction: Focusing on endoscopic approach. World J Gastrointest Pharmacol Ther. 2020 Jun 9;11(2):8-16. doi: 10.4292/wjgpt.v11.i2.8. Review. — View Citation

Jeurnink SM, Steyerberg EW, van Hooft JE, van Eijck CH, Schwartz MP, Vleggaar FP, Kuipers EJ, Siersema PD; Dutch SUSTENT Study Group. Surgical gastrojejunostomy or endoscopic stent placement for the palliation of malignant gastric outlet obstruction (SUSTENT study): a multicenter randomized trial. Gastrointest Endosc. 2010 Mar;71(3):490-9. doi: 10.1016/j.gie.2009.09.042. Epub 2009 Dec 8. — View Citation

Jeurnink SM, van Eijck CH, Steyerberg EW, Kuipers EJ, Siersema PD. Stent versus gastrojejunostomy for the palliation of gastric outlet obstruction: a systematic review. BMC Gastroenterol. 2007 Jun 8;7:18. Review. — View Citation

Kim CG, Choi IJ, Lee JY, Cho SJ, Park SR, Lee JH, Ryu KW, Kim YW, Park YI. Covered versus uncovered self-expandable metallic stents for palliation of malignant pyloric obstruction in gastric cancer patients: a randomized, prospective study. Gastrointest Endosc. 2010 Jul;72(1):25-32. doi: 10.1016/j.gie.2010.01.039. Epub 2010 Apr 9. — View Citation

Kim JH, Song HY, Shin JH, Choi E, Kim TW, Jung HY, Lee GH, Lee SK, Kim MH, Ryu MH, Kang YK, Kim BS, Yook JH. Metallic stent placement in the palliative treatment of malignant gastroduodenal obstructions: prospective evaluation of results and factors influencing outcome in 213 patients. Gastrointest Endosc. 2007 Aug;66(2):256-64. — View Citation

Laasch HU, Martin DF, Maetani I. Enteral stents in the gastric outlet and duodenum. Endoscopy. 2005 Jan;37(1):74-81. Review. — View Citation

Ly J, O'Grady G, Mittal A, Plank L, Windsor JA. A systematic review of methods to palliate malignant gastric outlet obstruction. Surg Endosc. 2010 Feb;24(2):290-7. doi: 10.1007/s00464-009-0577-1. Epub 2009 Jun 24. Review. — View Citation

Mehta S, Hindmarsh A, Cheong E, Cockburn J, Saada J, Tighe R, Lewis MP, Rhodes M. Prospective randomized trial of laparoscopic gastrojejunostomy versus duodenal stenting for malignant gastric outflow obstruction. Surg Endosc. 2006 Feb;20(2):239-42. Epub 2005 Dec 9. — View Citation

Mutignani M, Tringali A, Shah SG, Perri V, Familiari P, Iacopini F, Spada C, Costamagna G. Combined endoscopic stent insertion in malignant biliary and duodenal obstruction. Endoscopy. 2007 May;39(5):440-7. — View Citation

Oh SY, Edwards A, Mandelson MT, Lin B, Dorer R, Helton WS, Kozarek RA, Picozzi VJ. Rare long-term survivors of pancreatic adenocarcinoma without curative resection. World J Gastroenterol. 2015 Dec 28;21(48):13574-81. doi: 10.3748/wjg.v21.i48.13574. — View Citation

Phillips MS, Gosain S, Bonatti H, Friel CM, Ellen K, Northup PG, Kahaleh M. Enteral stents for malignancy: a report of 46 consecutive cases over 10 years, with critical review of complications. J Gastrointest Surg. 2008 Nov;12(11):2045-50. doi: 10.1007/s11605-008-0598-4. Epub 2008 Jul 22. — View Citation

Sasaki T, Isayama H, Nakai Y, Takahara N, Hamada T, Mizuno S, Mohri D, Yagioka H, Kogure H, Arizumi T, Togawa O, Matsubara S, Ito Y, Yamamoto N, Sasahira N, Hirano K, Toda N, Tada M, Koike K. Clinical outcomes of secondary gastroduodenal self-expandable metallic stent placement by stent-in-stent technique for malignant gastric outlet obstruction. Dig Endosc. 2015 Jan;27(1):37-43. doi: 10.1111/den.12321. Epub 2014 Aug 28. — View Citation

Sato T, Hara K, Mizuno N, Hijioka S, Imaoka H, Niwa Y, Tajika M, Tanaka T, Ishihara M, Shimizu Y, Bhatia V, Kobayashi N, Endo I, Maeda S, Nakajima A, Kubota K, Yamao K. Gastroduodenal stenting with Niti-S stent: long-term benefits and additional stent intervention. Dig Endosc. 2015 Jan;27(1):121-9. doi: 10.1111/den.12300. Epub 2014 Apr 22. — View Citation

Staub J, Siddiqui A, Taylor LJ, Loren D, Kowalski T, Adler DG. ERCP performed through previously placed duodenal stents: a multicenter retrospective study of outcomes and adverse events. Gastrointest Endosc. 2018 Jun;87(6):1499-1504. doi: 10.1016/j.gie.2018.01.040. Epub 2018 Feb 6. — View Citation

Storm AC, Ryou M. Advances in the endoscopic management of gastric outflow disorders. Curr Opin Gastroenterol. 2017 Nov;33(6):455-460. doi: 10.1097/MOG.0000000000000403. Review. — View Citation

Suder-Castro LS, Ramírez-Solís ME, Hernández-Guerrero AI, de la Mora-Levy JG, Alonso-Lárraga JO, Hernández-Lara AH. Predictors of self-expanding metallic stent dysfunction in malignant gastric outlet obstruction. Rev Gastroenterol Mex (Engl Ed). 2020 Jul - Sep;85(3):275-281. doi: 10.1016/j.rgmx.2019.07.009. Epub 2020 Mar 27. English, Spanish. — View Citation

Tringali A, Giannetti A, Adler DG. Endoscopic management of gastric outlet obstruction disease. Ann Gastroenterol. 2019 Jul-Aug;32(4):330-337. doi: 10.20524/aog.2019.0390. Epub 2019 May 30. Review. — View Citation

Tyberg A, Perez-Miranda M, Sanchez-Ocaña R, Peñas I, de la Serna C, Shah J, Binmoeller K, Gaidhane M, Grimm I, Baron T, Kahaleh M. Endoscopic ultrasound-guided gastrojejunostomy with a lumen-apposing metal stent: a multicenter, international experience. Endosc Int Open. 2016 Mar;4(3):E276-81. doi: 10.1055/s-0042-101789. — View Citation

van Hooft JE, Dijkgraaf MG, Timmer R, Siersema PD, Fockens P. Independent predictors of survival in patients with incurable malignant gastric outlet obstruction: a multicenter prospective observational study. Scand J Gastroenterol. 2010 Oct;45(10):1217-22. doi: 10.3109/00365521.2010.487916. — View Citation

Yamao K, Kitano M, Kayahara T, Ishida E, Yamamoto H, Minaga K, Yamashita Y, Nakajima J, Asada M, Okabe Y, Osaki Y, Chiba Y, Imai H, Kudo M. Factors predicting through-the-scope gastroduodenal stenting outcomes in patients with gastric outlet obstruction: a large multicenter retrospective study in West Japan. Gastrointest Endosc. 2016 Nov;84(5):757-763.e6. doi: 10.1016/j.gie.2016.03.1498. Epub 2016 Apr 4. — View Citation

Yang Z, Wu Q, Wang F, Ye X, Qi X, Fan D. A systematic review and meta-analysis of randomized trials and prospective studies comparing covered and bare self-expandable metal stents for the treatment of malignant obstruction in the digestive tract. Int J Med Sci. 2013 Apr 27;10(7):825-35. doi: 10.7150/ijms.5969. Print 2013. Review. — View Citation

* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of immediate adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.	To evaluate the proportion of patients that presents with bleeding , prostheses misplacement or perforation.	Adverse events will be recorded during the first 24 hours of the procedure
Primary	Incidence of early-term adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.	we will record the proportion of patients that presents with migration, clogging, stenosis at gastro-enterostomy site or leakage.	Adverse events will be recorded after the first day up to 30 days of the procedure
Primary	Incidence of mid-term adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.	we will record the proportion of patients that presents with migration, clogging, stenosis at gastro-enterostomy site or leakage.	Adverse events will be recorded from the first month up to the third month after procedure
Primary	Incidence of long-term adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.	we will record the proportion of patients that presents with migration, clogging, stenosis at gastro-enterostomy site or leakage.	Adverse events will be recorded after the third month of the stent placement up to study completion, an average of 6 months
Primary	Incidence of the correct stent placement for endoscopic ultrasound gastro-enterostomy anastomosis creation at the desired loop	Technical success: We will determine the ability to place the stents in the desired loop and in a correct position.	During each procedure correct stent placement will be assessed
Secondary	Improvement in tolerance to oral feeding assessed by the gastric outlet obstruction scoring system (GOOSS) in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy	Clinical success: Defined as an increase in tolerance to oral feeding, assessed by GOOSS: 0 = no/inadequate oral intake, 1 = liquids/thickened liquids, 2 = semisolids/low residue diet, 3 = unmodified diet. A higher score means a better outcome.	Immediately after the intervention/procedure/surgery and every month through study completion, an average of 6 months
Secondary	Changes in quality of life assessed by the self-report health-related quality of life questionnaire in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.	Quality of life will be measured with the short form survey (SF-36 questionnaire). It consists of physical and mental component scores ranging from 0 to 100; a higher scores means a better outcome, a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	Baseline and every month after the intervention/procedure/surgery through study completion, an average of 6 months.
Secondary	Changes of functional impairment assessed by Karnofsky Performance Scale Index in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.	The Karnofsky Performance Scale Index allows patients to be classified as to their functional impairment. The lower scores means worst prognosis: 100-80 means that the patient is able to perform normal activities; 70-50 points means that the patient is unable to work; able to live at home and care for most personal needs, and 40-0 points means that the patient is unable to care for self; requires equivalent of hospital care and disease may be progressing rapidly.	Baseline and every month after the intervention/procedure/surgery through study completion, an average of 6 months.
Secondary	Changes in functional status with Eastern Cooperative Oncology Group (ECOG) performance scale in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.	The ECOG Scale of performance status describes patients functionality. Lower points means best outcomes.0: fully active. 1: Restricted in some physical activities. 2: Capable of all self-care but unable to carry our any work activities, more than 50% of walking hours. 3: limited self-care, confined to bed or chair more tan 50% of walking hours. 4: Completely disabled. Totally confined to bed or chair. 5: Dead.	Baseline and every month after the intervention/procedure/surgery through study completion, an average of 6 months.