Clinical trial · Interventional
Enteral Anastomosis for the Treatment of Gastric Outlet Obstruction: A Randomized Controlled Study Comparing Endoscopic Versus Surgical Gastrojejunostomy
NCT05561907CI-TRIAL-00114683EAT-GOrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Gastric outlet obstruction (GOO) occurs commonly in malignancies involving the periampullary region (cancers originating in the head of the pancreas, duodenum, bile duct, or ampulla) or the distal stomach. GOO not only causes debilitating symptoms such as nausea, vomiting, inability to tolerate oral intake, and prevents adequate nutritional intake. Therefore, providing therapy for GOO is imperative to improve the quality of life, and nutritional status of these patients, as well as allow them to continue receiving their cancer treatment
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 |
|---|---|---|---|
| Gastric Outlet Obstruction | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic gastrojejunostomy (EGJ) | Procedure | — | UNRESOLVED |
| Surgical gastrojejunostomy (SGJ) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Surgical gastrojejunostomy (SGJ)
- description
- An anastomosis will be created between the stomach and the proximal loop of the jejunum during a laparoscopic surgical procedure.
- interventionNames
- Procedure: Surgical gastrojejunostomy (SGJ)
- type
- EXPERIMENTAL
- label
- Endoscopic gastrojejunostomy (EGJ)
- description
- A stent is placed between the stomach and adjacent small intestine under endoscopic ultrasound guidance during an upper endoscopic procedure.
- interventionNames
- Procedure: Endoscopic gastrojejunostomy (EGJ)
Primary outcomes (1)
- measure
- Time to initiation of solid oral intake without symptoms of GOO
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Periampullary malignancy (pancreas, bile duct, ampulla, duodenum) extending to the distal duodenum (D3) or distal (antrum) gastric cancer 2. Symptoms of gastric outlet obstruction (at least 2 of 4 required): 1. post prandial vomiting, 2. abdominal pain, 3. inability to tolerate PO, 4. imaging consistent with GOO 3. Gastric Outlet Obstruction Scoring System (GOOSS) Score of 0 (no oral intake) or 1 (liquids only) 4. Age \>18 years old 5. Life expectancy greater than 2 months or failed duodenal stenting 6. Surgical Candidate/Tolerate General Anesthesia 7. Unresectable or metastatic disease Exclusion Criteria: 1. Age\< 18 years old 2. Pregnancy 3. Intestinal obstruction distal to the Ligament of Treitz 4. Evidence of other luminal strictures of the GI tract 5. Previous gastric or periampullary surgery 6. Inability to complete quality of life surveys (QOLS) 7. Presence of abdominal ascites
References
Publications (26)
- BACKGROUNDLorusso D, Giliberti A, Bianco M, Lantone G, Leandro G. Stomach-partitioning gastrojejunostomy is better than conventional gastrojejunostomy in palliative care of gastric outlet obstruction for gastric or pancreatic cancer: a meta-analysis. J Gastrointest Oncol. 2019 Apr;10(2):283-291. doi: 10.21037/jgo.2018.10.10. PMID 31032096
- BACKGROUNDTroncone E, Fugazza A, Cappello A, Del Vecchio Blanco G, Monteleone G, Repici A, Teoh AYB, Anderloni A. Malignant gastric outlet obstruction: Which is the best therapeutic option? World J Gastroenterol. 2020 Apr 28;26(16):1847-1860. doi: 10.3748/wjg.v26.i16.1847. PMID 32390697
- BACKGROUNDMaetani I, Inoue H, Sato M, Ohashi S, Igarashi Y, Sakai Y. Peroral insertion techniques of self-expanding metal stents for malignant gastric outlet and duodenal stenoses. Gastrointest Endosc. 1996 Oct;44(4):468-71. doi: 10.1016/s0016-5107(96)70102-5. PMID 8905371
- BACKGROUNDTonozuka R, Tsuchiya T, Mukai S, Nagakawa Y, Itoi T. Endoscopic Ultrasonography-Guided Gastroenterostomy Techniques for Treatment of Malignant Gastric Outlet Obstruction. Clin Endosc. 2020 Sep;53(5):510-518. doi: 10.5946/ce.2020.151. Epub 2020 Sep 23. PMID 32962331
- BACKGROUNDKhashab 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. PMID 23299137
- BACKGROUNDJeurnink 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.