Endoscopic ultrasonography-guided gastroenterostomy versus surgical gastrojejunostomy for palliation of malignant gastric outlet obstruction (ENDURO-study)

Endoscopic ultrasonography-guided gastroenterostomy versus surgical gastrojejunostomy for palliation of malignant gastric outlet obstruction

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25505

Enrollment

Registered

2021-07-07

Start date

2022-02-01

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant gastric outlet obstruction

Interventions

EUS-guided gastroenterostomy versus surgical gastrojejunostomy

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible for this study, a subject must meet all of the following criteria: - Adult patients with symptomatic malignant gastric outlet obstruction, presenting with nausea, vomiting and/or inability to eat; - Gastric Outlet Obstruction Scoring System Score of 0 (no oral intake) or 1 (liquids only); - Obstruction due to irresectable or metastatic malignancy without curative treatment options; - Radiologically or endoscopically confirmed gastric outlet obstruction; - Location of obstruction extending from the pyloric region to the distal duodenum (third part). - Both treatments (SGJ and EUS-GE) are technically and clinically feasible; - Written informed consent.

Exclusion criteria

Exclusion criteria: - Radiological or clinical suspicion of other strictures or obstructions along the gastrointestinal tract (distal of the ligament of Treitz), with small intestinal dilation/ileus. Note: patients with diffuse dilatation of the intestines should not be excluded; - Cancer extending into the distal region or corpus of the stomach or around the ligament of Treitz. These types may pose a risk of negatively affecting gastrointestinal motility next to causing gastric outlet obstruction. - Duodenal tube feeding is not tolerated, despite adequate position of the tube; - Altered anatomy after previous gastric, periampullary or duodenal surgery; - Previous SGJ as palliative treatment for the same condition; - Inability to undergo surgery or upper endoscopy due to severe comorbidities (including large-volume ascites); - WHO performance score of 4 (in bed 100% of time); - Uncorrectable coagulopathy, defined by INR > 1.5 or platelets < 50 x 109/L;

Design outcomes

Primary

Measure	Time frame
Our main study parameter is the ability to eat. This will be measured with two co-primary endpoints, covering the short- and long-term effects: 1a. Time to oral intake of soft solids is defined as the number of days until a patient is able to tolerate soft solids (GOOSS = 2) without vomiting. Day of intervention is considered day 0. 1b. Persistent or recurrent GOO symptoms requiring reintervention is defined as any new intervention after EUS-GE or SGJ directed at improving or restoring nutritional intake, in case of persistent or recurrent obstructive symptoms of gastric outlet obstruction, such as nausea, vomiting or inability to tolerate oral intake (GOOSS 0-1).	—

Measure

Time frame

Our main study parameter is the ability to eat. This will be measured with two co-primary endpoints, covering the short- and long-term effects: 1a. Time to oral intake of soft solids is defined as the number of days until a patient is able to tolerate soft solids (GOOSS = 2) without vomiting. Day of intervention is considered day 0. 1b. Persistent or recurrent GOO symptoms requiring reintervention is defined as any new intervention after EUS-GE or SGJ directed at improving or restoring nutritional intake, in case of persistent or recurrent obstructive symptoms of gastric outlet obstruction, such as nausea, vomiting or inability to tolerate oral intake (GOOSS 0-1).

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Secondary

Measure	Time frame
Our secondary endpoints are defined as follows: 2. Technical success is defined as successful creation of a gastroenterostomy by means of the allocated technique (EUS-GE or SGJ). Successful (stent-in-stent) placement of a second Hot AXIOS stent during the same procedure after the initial attempt failed is also considered technically successful. If additional techniques, modalities or different type of stents (e.g. self-expandable metallic stents) were required, it will be regarded as technical failure. 3. Clinical success is defined as relief of symptoms and toleration of soft solids (GOOSS =2) without vomiting. 4. Gastroenterostomy dysfunction is defined as recurrence of obstructive symptoms (GOOSS 0-1) due to recurrence of GOO at the gastroenterostomy site after initial clinical success, confirmed endoscopically or radiographically. 5. Reintervention is defined as any endoscopic or surgical intervention for an adverse event, persistent obstructive symptoms or recurrent obstructive symptoms, that is needed after EUS-GE or SGJ. This includes creating an alternative route to improve or restore adequate nutritional intake – either through placing a nasal feeding tube, construction of a gastrostomy or jejunostomy, or through initiating parenteral nutrition. 6. Time to reintervention for recurrence of symptoms is defined as the time in days between EUS-GE/SGJ and reintervention for recurrence of symptoms of GOO (nausea, vomiting, inability to tolerate oral intake). 7. Adverse events are specified according to the ASGE lexicon for endoscopic adverse events. An adverse event is defined as “an event that prevents completion of the planned procedure and/or results in admission to hospital, prolongation of existing hospital stay, another procedure (needing sedation/anesthesia), or subsequent medical consultation.”30 Late adverse events are considered events occurring beyond thirty days after the study procedure. Severity of adverse events is graded according to the Clavie	—

Measure

Time frame

Our secondary endpoints are defined as follows: 2. Technical success is defined as successful creation of a gastroenterostomy by means of the allocated technique (EUS-GE or SGJ). Successful (stent-in-stent) placement of a second Hot AXIOS stent during the same procedure after the initial attempt failed is also considered technically successful. If additional techniques, modalities or different type of stents (e.g. self-expandable metallic stents) were required, it will be regarded as technical failure. 3. Clinical success is defined as relief of symptoms and toleration of soft solids (GOOSS =2) without vomiting. 4. Gastroenterostomy dysfunction is defined as recurrence of obstructive symptoms (GOOSS 0-1) due to recurrence of GOO at the gastroenterostomy site after initial clinical success, confirmed endoscopically or radiographically. 5. Reintervention is defined as any endoscopic or surgical intervention for an adverse event, persistent obstructive symptoms or recurrent obstructive symptoms, that is needed after EUS-GE or SGJ. This includes creating an alternative route to improve or restore adequate nutritional intake – either through placing a nasal feeding tube, construction of a gastrostomy or jejunostomy, or through initiating parenteral nutrition. 6. Time to reintervention for recurrence of symptoms is defined as the time in days between EUS-GE/SGJ and reintervention for recurrence of symptoms of GOO (nausea, vomiting, inability to tolerate oral intake). 7. Adverse events are specified according to the ASGE lexicon for endoscopic adverse events. An adverse event is defined as “an event that prevents completion of the planned procedure and/or results in admission to hospital, prolongation of existing hospital stay, another procedure (needing sedation/anesthesia), or subsequent medical consultation.”30 Late adverse events are considered events occurring beyond thirty days after the study procedure. Severity of adverse events is graded according to the Clavie

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Contacts

Public ContactYorick van de Pavert

UMC Utrecht

y.l.vandepavert@umcutrecht.nl0887560034

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)