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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EUS-guided gastroenterostomy (EUS-GE) | Active Comparator | 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. |
|
| Enteral Stenting (ES) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumen-apposing metal stent | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Gastric Outlet Obstruction Recurrence | Defined as percentage of participants with recurrence of nausea, vomiting, and inability to tolerate PO intake up to 12 months after the procedure confirmed either endoscopically and/or radiographically. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success Rate | Participants with adequate positioning and deployment of the stent(s) as determined endoscopically and radiographically. | Day of procedure |
| Participants With Improved Clinical Success Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mouen A. Khashab, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06520 | United States | ||
| The Johns Hopkins Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14760669 | Background | 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. | |
| 15457364 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | EUS-guided Gastroenterostomy (EUS-GE) | In this technique, a lumen-apposing metal stent is deployed between the gastric wall and its adjacent small intestine to keep the stomach-small intestine connection open. |
| FG001 | Enteral Stenting (ES) | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EUS-guided Gastroenterostomy (EUS-GE) | In this technique, a lumen-apposing metal stent is deployed between the gastric wall and its adjacent small intestine to keep the stomach-small intestine connection open. |
| BG001 | Enteral Stenting (ES) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Gastric Outlet Obstruction Recurrence | Defined as percentage of participants with recurrence of nausea, vomiting, and inability to tolerate PO intake up to 12 months after the procedure confirmed either endoscopically and/or radiographically. | Patients without post-randomization follow-up data collected were excluded from time-to-event analyses (1 in EUS-GE group and 3 in ES group. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 12 months |
|
Up to 12 months
Adverse events were reported based on ASGE Lexicon
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EUS-guided Gastroenterostomy (EUS-GE) | In this technique, a lumen-apposing metal stent is deployed between the gastric wall and its adjacent small intestine to keep the stomach-small intestine connection open. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Perforation | Gastrointestinal disorders | Systematic Assessment | Delayed perforation at 7 months from tumor ingrowth with pneumoperitoneum, managed conservatively with antibiotics. It was graded as Moderate based on the ASGE Lexicon. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emesis | Gastrointestinal disorders | Systematic Assessment | Persistent vomiting after the procedure managed conservatively. It was graded as Mild based on the ASGE Lexicon. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mouen A. Khashab, MD | Johns Hopkins University | Not Available | mkhasha1@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 17, 2025 | Jun 8, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017219 | Gastric Outlet Obstruction |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069322 | Self Expandable Metallic Stents |
| ID | Term |
|---|---|
| D015607 | Stents |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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Patients will be randomly allocated with a 1:1 ratio to one of the study arms (EUS-GE or ES)
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|
| Self-expandable metal stent | Device | 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. |
|
Participants with improvement of at least 1 point in the gastric outlet obstruction score range 0-3 (0 as no oral intake to 3 as complete diet) within 7 days after stent insertion. Higher score better.
| 1 week |
| Length of Procedure | Duration of the procedure (minutes) | Day of procedure |
| Participants With Adverse Events | Participants with Adverse events based on ASGE Lexicon | 12 months |
| Post-procedure Length of Hospital Stay | Duration of hospitalization following the procedure, measured in days from the date of the procedure to the date of hospital discharge. | 1 week |
| Reintervention Rate for Recurrent Gastric Outlet Obstruction | Reintervention (endoscopic or surgical) for stent dysfunction causing recurrent gastric outlet obstruction | 12 months |
| 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 |
| Overall Survival Rate | Percentage of participants surviving at 12 months after randomization, regardless of cause of death. | 1 year |
| Time in Days to Recurrent Gastric Outlet Obstruction | Time from the procedure to the start of recurrent gastric outlet obstruction symptoms and signs due to stent dysfunction | 12 months |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| Wake Forest Baptist University | Winston-Salem | North Carolina | 27157 | United States |
| The Research Institute of McGill University Health Centre | Montreal | Quebec | Canada |
| Ecuadorian Institute of Digestive Diseases (IECED) | Guayaquil | Ecuador |
| Hospital Prive des Peupliers | Paris | France |
| Asian Institute of Gastroenterology | Hyderabad | India |
| Emek Medical Center | Afula | 1834111 | Israel |
| Hospital Universitario Rio Hortega | Valladolid | 47012 | Spain |
| 16261429 | Background | 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. |
| 23299137 | Background | 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. |
| 26215646 | Background | 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. |
| 28032663 | Background | 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. |
| 27834024 | Background | 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. |
| 20189503 | Background | 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. |
| 11808972 | Background | 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. |
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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Two patients in the ES group had missing data. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Malignancy Diagnosis | Count of Participants | Participants |
|
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. |
|
|
| Secondary | Technical Success Rate | Participants with adequate positioning and deployment of the stent(s) as determined endoscopically and radiographically. | Posted | Count of Participants | Participants | Day of procedure |
|
|
|
| Secondary | Participants With Improved Clinical Success Rate | Participants with improvement of at least 1 point in the gastric outlet obstruction score range 0-3 (0 as no oral intake to 3 as complete diet) within 7 days after stent insertion. Higher score better. | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Secondary | Length of Procedure | Duration of the procedure (minutes) | Participants with data collected | Posted | Mean | Standard Deviation | Minutes | Day of procedure |
|
|
|
| Secondary | Participants With Adverse Events | Participants with Adverse events based on ASGE Lexicon | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Post-procedure Length of Hospital Stay | Duration of hospitalization following the procedure, measured in days from the date of the procedure to the date of hospital discharge. | Participants with data collected | Posted | Mean | Standard Deviation | days | 1 week |
|
|
|
| Secondary | Reintervention Rate for Recurrent Gastric Outlet Obstruction | Reintervention (endoscopic or surgical) for stent dysfunction causing recurrent gastric outlet obstruction | Patients without post-randomization follow-up data collected were excluded from time-to-event analyses (1 in EUS-GE group and 3 in ES group. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 12 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. | Participants with data collected | Posted | Mean | 95% Confidence Interval | Baseline adjusted mean score | 3 months |
|
|
|
| Secondary | Overall Survival Rate | Percentage of participants surviving at 12 months after randomization, regardless of cause of death. | Patients without post-randomization follow-up data collected were excluded from time-to-event analyses (1 in EUS-GE group and 3 in ES group. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 1 year |
|
|
|
| Secondary | Time in Days to Recurrent Gastric Outlet Obstruction | Time from the procedure to the start of recurrent gastric outlet obstruction symptoms and signs due to stent dysfunction | Only participants with recurrent gastric outlet obstruction due to stent dysfunction were included in the analyses. Eight patients in the ES group had recurrent gastric outlet obstruction, but there was no recurrence of gastric outlet obstruction in the EUS-GE group. | Posted | Median | Full Range | days | 12 months |
|
|
|
| 44 |
| 57 |
| 0 |
| 57 |
| 4 |
| 57 |
| EG001 | Enteral Stenting (ES) | 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. | 45 | 55 | 3 | 55 | 1 | 55 |
|
| Stent migration | Gastrointestinal disorders | Systematic Assessment | Stent migration at 1-week post-procedure presenting with jaundice, managed with overlapping enteral stent. It was graded as Moderate based on the ASGE Lexicon. |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Intraprocedural aspiration during intubation requiring ICU admission and bronchoscopy, with extubation on day 1. It was graded as Severe based on the ASGE Lexicon. |
|
|
| Stent misdeployment | Gastrointestinal disorders | Systematic Assessment | Stent misdeployment during balloon dilation, requiring immediate endoscopic rescue and placement of a second stent, which resulted in prolonged hospitalization and was graded as Mild based on the ASGE lexicon. |
|
| Stent-related pressure ulceration | Gastrointestinal disorders | Systematic Assessment | Stent-related jejunal pressure ulceration identified at 3 months in a patient with nausea/vomiting; the stent was removed after identifying a downstream jejunal stricture from metastatic disease. It was graded as Mild based on the ASGE Lexicon. |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment | Diarrhea on day 1 post-procedure (negative Clostridium difficile and viral testing) that resolved after four days. It was graded as Mild based on the ASGE Lexicon. |
|
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Duodenal or Ampullary Cancer |
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| Other |
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| Role limitations due to emotional problems |
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| Energy/fatigue |
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| Emotional well-being |
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| Social functioning |
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| Bodily pain |
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| General health |
|