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NCT06567691 | NOT YET RECRUITING | Malignant Gastric Outlet Obstruction

Endoscopic Gastroenterostomy Versus Surgical Gastrojejunostomy
Sponsor:

Vanderbilt University Medical Center

Information provided by (Responsible Party):

Patrick Yachimski

Brief Summary:

Recent comparative data suggest that EUS gastroenterostomy offers more durable patency than enteral stents for treatment of malignant GOO, leading some endoscopists to suggest that EUS gastroenterostomy should be the preferred endoscopic treatment approach. EUS gastroenterostomy and surgical gastrojejunostomy have been compared in retrospective cohort analysis, suggesting a high technical success rate a shorter hospital length of stay for the endoscopic approach \[4\]. Comparison of these techniques has not been reported in controlled prospective fashion. A prospective trial is necessary in order to define the optimal interventional management option for treatment of malignant GOO in the context of the contemporary and rapidly evolved range of available endoscopic and surgical treatment options.

Condition or disease

Malignant Gastric Outlet Obstruction

Intervention/treatment

EUS Gastrojejunostomy

Surgical Gastrojejunostomy

Gastric Outlet Obstruction Scoring System (GOOSS)

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 34 participants
Masking : NONE
Masking Description : Due to the nature and means of access of the two interventions (one via peroral approach and one via abdominal incision) blinding of the subjects, study investigators, and treating clinicians will not be practicable short of subjecting patients to sham endoscopy and/or surgery, which we feel would be unethical.
Primary Purpose : SUPPORTIVE_CARE
Official Title : Endoscopic Gastroenterostomy Versus Surgical Gastrojejunostomy for Treatment of Malignant Gastric Outlet Obstruction: a Randomized Controlled Trial
Actual Study Start Date : 2025-01
Estimated Primary Completion Date : 2027-01
Estimated Study Completion Date : 2027-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Age 18 years or older
  • * Able to provide informed consent
  • * Biopsy-proven cancer
  • * Cancer without surgical resection as a curative treatment option
  • * Clinical and radiographic presentation consistent with primary or metastatic tumor causing foregut obstruction at the level of the pylorus and/or duodenum
Exclusion Criteria
  • * Age \<18 years
  • * Pregnancy
  • * Unable to provide informed consent
  • * White Blood Count \< 3,000
  • * Absolute Neutrophil Count \< 1,500
  • * International normalized ratio \> 1.6
  • * Platelet count \< 100,000
  • * Cancer with surgical resection as a curative treatment option
  • * Surgically altered foregut anatomy
  • * Multifocal intestinal obstruction
  • * Abdominal ascites prohibitive of surgical candidacy
  • * Abdominal wall mesh prohibitive of surgical candidacy
  • * Child's Class B or C cirrhosis
  • * Gastroesophageal varices or known portal hypertension
  • * Body mass index \>40
Endoscopic Gastroenterostomy Versus Surgical Gastrojejunostomy

Location Details

NCT06567691

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Locations

Not yet recruiting

United States, Tennessee

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37212