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Clinical Trials/CTRI/2022/11/047173
CTRI/2022/11/047173
Recruiting
Phase 3

Endoscopic ultrasound guided gastrojejunostomy versus laparoscopic gastrojejunostomy for palliative management of malignant gastric outlet obstruction: a randomized controlled trial

Dr Jayanta Samanta0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: C269- Malignant neoplasm of ill-definedsites within the digestive system

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: C269- Malignant neoplasm of ill-definedsites within the digestive system
Sponsor
Dr Jayanta Samanta
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Dr Jayanta Samanta

Eligibility Criteria

Inclusion Criteria

  • •1\.Patients \= 18 years of age with malignant symptomatic gastric outlet obstruction (GOO) requiring intervention with an unresectable malignant lesion (biopsy proven) or borderline/ locally advanced planned for neo\-adjuvant therapy prior to surgery.
  • •2\.GOO confirmed endoscopically or radiologically.
  • •3\.GOOS (gastric outlet obstruction score) 0 (no oral intake) or 1 (only liquids).
  • •4\.The patient who gives informed consent for participation in the study.

Exclusion Criteria

  • •1\.Lack of informed consent
  • •2\.Pregnancy
  • •3\.Coagulation disorder (INR \>1\.5 or platelet count \<50000/ul)
  • •4\.Multiple level bowel obstruction confirmed radiologically (contrast study or computed tomography scans)
  • •5\.Prior endoscopic or surgical treatment for GOO.
  • •6\.Severe comorbidities precluding endoscopic treatment (cardiorespiratory instability, severe pulmonary disease, bleeding disorder)
  • •7\.Previous gastric, periampullary or duodenal surgery
  • •8\.Complete GOO evidenced by inability to either pass a wire/nasojejunal tube across the stricture and/or inability to opacify small bowel distal to the malignant stricture
  • •9\.Malignant conditions involving the stomach such as Linitis plastica, malignancy of the proximal stomach etc.
  • •10\.Life expectancy of less than 1 month

Outcomes

Primary Outcomes

Not specified

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