Clinical trial · Interventional
Prophylactic EUS-guided Gastroenterostomy in Advanced Periampullary Cancers
Prophylactic EUS-guided Gastroenterostomy in Advanced Periampullary Cancers: a Multicenter Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this randomized controlled trial is to investigate the effectiveness and safety of Prophylactic EUS-gastroenterostomy (ProEUS-GE) as a preventative approach for malignant gastric outlet obstruction (MGOO) in men and women aged 18 years or older diagnosed with periampullary cancer. The main question this study aims to answer is can ProEUS-GE effectively prevent the occurrence of MGOO in patients with periampullary cancer? Patients will be randomly assigned to one of two groups: Group 1 (ERCP alone) or Group 2 (ERCP + ProEUS-GE). The study will compare the outcomes between these groups to determine the effectiveness of ProEUS-GE in preventing MGOO. Researchers will compare Group 1 (ERCP alone) with Group 2 (ERCP + ProEUS-GE) to see if the addition of ProEUS-GE leads to a reduced occurrence of MGOO in patients with periampullary cancer. The primary endpoint is the rate of malignant gastric outlet obstruction.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Gi | Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ERCP alone | Procedure | — | UNRESOLVED |
| ERCP +ProEUS-GE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ERCP alone
- description
- ERCP procedure alone and management of MGOO will be on a wait-and-see approach, using endoscopic interventions performed only if obstruction is clinically diagnosed
- interventionNames
- Procedure: ERCP alone
- type
- EXPERIMENTAL
- label
- ERCP + ProEUS-GE
- description
- ERCP with prophylactic eus-guided gastroenterostomy
- interventionNames
- Procedure: ERCP +ProEUS-GE
Primary outcomes (1)
- measure
- Rate of gastric outlet obstruction (GOO)
- timeFrame
- 18 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria (all of the following): 1. Radiological diagnosis of a periampullary cancer that is precluded from upfront surgical resection of curative intent due to advanced tumor stage. These include locally advanced or metastatic cancers of the pancreatic head, distal bile duct, duodenum, or ampulla. cancers. 2. Elevated liver function tests requiring ERCP without evidence of MGOO of significant gastroparesis (see exclusion criterion #3 and #4) 3. ECOG 0 or 1 4. ASA\<4 5. Provision of informed consent Exclusion Criteria (any of the following): 1. Patient with clinical and radiological evidence of malignant gastric outlet obstruction defined as Gastric Outlet Obstruction Scoring System (GOOSS) of \< 3 with radiological and/or endoscopic evidence of a mechanical obstruction from a gastric or duodenal stricture. GOOSS is a validated tool for assessing MGOO and is scored based on the diet tolerated by the patient: 0 for no oral intake, 1 for liquids only, 2 for soft diet, and 3 for low residue or full diet. 2. Gastroparesis with a Gastroparesis Cardinal Symptom Index (GCSI) of \>2. Gastroparesis is defined as having symptoms of MGOO without radiological and/or endoscopic evidence of mechanical obstruction. 3. Uncorrectable coagulopathy and/or thrombocytopenia 4. Age \< 18 or ≥ 85 5. Evidence of peritoneal carcinomatosisAscites 6. Liver metastasis \> 30% of the liver volume 7. Portal hypertension with gastroesophageal varices and/or ascites 8. Surgically altered upper gastrointestinal anatomy
References
Publications (0)
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