Endoscopic Gastroenterostomy Versus Surgical Gastrojejunostomy

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Aug 20, 2024

Keywords

ClinConnect Summary

This clinical trial is comparing two methods for treating a condition called malignant gastric outlet obstruction (GOO), which happens when a tumor blocks the stomach and prevents food from passing through. The two methods being studied are endoscopic gastroenterostomy, a less invasive procedure done through the mouth, and surgical gastrojejunostomy, which involves a more traditional surgical approach. The goal is to determine which method works better and allows patients to recover faster and stay in the hospital for a shorter time.

To participate in this trial, you must be at least 18 years old and have a confirmed diagnosis of cancer that cannot be cured with surgery. You also need to be able to give consent and have certain health criteria that allow for safe treatment. If you meet these requirements, you can expect to receive either the endoscopic or surgical procedure and will be closely monitored throughout the trial. This study is important because it aims to find the best treatment option for patients facing this challenging condition, and it has not been done in a controlled setting before.

Gender

ALL

Eligibility 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