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Malignant Gastric Outlet ObstructionNCT04810377

Endoscopic Ultrasound-Guided Gastroenterostomy for Malignant Gastric Outlet Obstruction

A study testing EUS-guided gastroenterostomy in people with Malignant Gastric Outlet Obstruction, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Malignant Gastric Outlet Obstruction
What is being tested?
EUS-guided gastroenterostomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteMexico
Study dates
1 Jan 2021to 1 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Centro Medico Nacional Siglo XXI Hospital de Especialidades

    Mexico City, Mexico City, 06700

Other trials in Mexico

About this study

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

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.

Read the detailed 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.

Being tested
EUS-guided gastroenterostomy
Keywords
EUS-Guided gastro-enterostomy, Safety, Efficacy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EUS-guided gastroenterostomyProcedure or surgery

    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.

Study groups in NCT04810377
Study groupRoleWhat they receive
EUS-guided gastroenterostomy in malignant gastric outlet obstructionExperimentalThe patients with malignant gastric outlet obstruction will be confirmed as follows: Histopathological report of cancer, thoracoabdominal tomography and impaired tolerance to oral feeding (tolerance to liquids only or null).
Receives: Procedure: EUS-guided gastroenterostomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Adverse events will be recorded during the first 24 hours of the procedure

  2. 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.

    Measured: Adverse events will be recorded after the first day up to 30 days of the procedure

  3. 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.

    Measured: Adverse events will be recorded from the first month up to the third month after procedure

  4. 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.

    Measured: Adverse events will be recorded after the third month of the stent placement up to study completion, an average of 6 months

  5. 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.

    Measured: During each procedure correct stent placement will be assessed

Secondary outcomes (4)

  1. 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.

    Measured: Immediately after the intervention/procedure/surgery and every month through study completion, an average of 6 months

  2. 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.

    Measured: Baseline and every month after the intervention/procedure/surgery through study completion, an average of 6 months.

  3. 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.

    Measured: Baseline and every month after the intervention/procedure/surgery through study completion, an average of 6 months.

  4. 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.

    Measured: Baseline and every month after the intervention/procedure/surgery through study completion, an average of 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2021
  2. Study start1 Jan 2021
  3. Primary completion1 Apr 2025
  4. Study completion1 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a prospective study that evaluates EUS-guided gastroenterostomy in a group of participants with diagnosis of malignant gastric outlet obstruction. Patients are sequentially recruited as diagnosed.
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04810377
Sponsor's protocol ID
R-2020-3601-298
Status last verified
Apr 2025
First submitted
18 Feb 2021
Last updated
24 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Suder-Castro LS, Ramirez-Solis ME, Hernandez-Guerrero AI, de la Mora-Levy JG, Alonso-Larraga JO, Hernandez-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.

    PubMed 32229056

  • 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.

    PubMed 31263354

  • 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.

    PubMed 32550041

  • 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.

    PubMed 28984645

  • Laasch HU, Martin DF, Maetani I. Enteral stents in the gastric outlet and duodenum. Endoscopy. 2005 Jan;37(1):74-81. doi: 10.1055/s-2004-826103. No abstract available.

    PubMed 15657863

  • Balderramo DC. [Gastric outlet obstruction]. Rev Esp Enferm Dig. 2008 Feb;100(2):98-9. doi: 10.4321/s1130-01082008000200007. No abstract available. Spanish.

    PubMed 18366268

  • 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.

    PubMed 21898024

  • 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.

    PubMed 20003966

  • 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.

    PubMed 30725254

  • 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. doi: 10.1186/1471-230X-7-18.

    PubMed 17559659

  • Espinel J, Vivas S, Munoz 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. doi: 10.1023/a:1012378509762.

    PubMed 11713929

  • 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.

    PubMed 18648893

  • Tyberg A, Perez-Miranda M, Sanchez-Ocana R, Penas 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.

    PubMed 27004243

  • 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.

    PubMed 30391433

  • 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.

    PubMed 11808972

Questions about this trial

What is this clinical trial studying?

A study testing EUS-guided gastroenterostomy in people with Malignant Gastric Outlet Obstruction, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of immediate adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy. (time frame: Adverse events will be recorded during the first 24 hours of the procedure). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04810377, which also lists 40 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.

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