Clinical trial · Interventional
Outpatient Percutaneous Radiologic Gastrostomy in Patients With Head and Neck Tumors
NCT03252509CI-TRIAL-00051228completedN/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)
This study intends to evaluate the security and success rate of large bore percutaneous radiologic gastrostomy in patients with head and neck tumors, as a outpatient procedure.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrostomy | — | UNRESOLVED | — |
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Percutaneous radiologic gastrostomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Percutaneous radiologic gastrostomy.
- description
- Outpatient percutaneous radiologic gastrostomy in patients with head and neck tumors before, during or after the oncologic treatment.
- interventionNames
- Procedure: Percutaneous radiologic gastrostomy
Primary outcomes (1)
- measure
- Complication rate.
- timeFrame
- Up to 24 weeks.
- description
- Rate of other complications like bleeding, infection, cutaneous fistulae.
Secondary outcomes (5)
- measure
- Duration of gastrostomy.
- timeFrame
- Up to 24 weeks.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Surgical risk ASA I-III, Karnofsky Performance Status \>70, acceptance and comprehension of the orientations and after-care, adequate social a familiar support, easy access to the hospital. Exclusion Criteria: * patients who live more than one hour away from the hospital, coagulopathies, refuse to join the protocol.
References
Publications (20)
- BACKGROUNDCampoli PM, Cardoso DM, Turchi MD, Ejima FH, Mota OM. Assessment of safety and feasibility of a new technical variant of gastropexy for percutaneous endoscopic gastrostomy: an experience with 435 cases. BMC Gastroenterol. 2009 Jun 26;9:48. doi: 10.1186/1471-230X-9-48. PMID 19558672
- BACKGROUNDCantwell CP, Perumpillichira JJ, Maher MM, Hahn PF, Arellano R, Gervais DA, Mueller PR. Antibiotic prophylaxis for percutaneous radiologic gastrostomy and gastrojejunostomy insertion in outpatients with head and neck cancer. J Vasc Interv Radiol. 2008 Apr;19(4):571-5. doi: 10.1016/j.jvir.2007.11.012. PMID 18375303
- BACKGROUNDCosentini EP, Sautner T, Gnant M, Winkelbauer F, Teleky B, Jakesz R. Outcomes of surgical, percutaneous endoscopic, and percutaneous radiologic gastrostomies. Arch Surg. 1998 Oct;133(10):1076-83. doi: 10.1001/archsurg.133.10.1076. PMID 9790204
- BACKGROUNDFoster JM, Filocamo P, Nava H, Schiff M, Hicks W, Rigual N, Smith J, Loree T, Gibbs JF. The introducer technique is the optimal method for placing percutaneous endoscopic gastrostomy tubes in head and neck cancer patients. Surg Endosc. 2007 Jun;21(6):897-901. doi: 10.1007/s00464-006-9068-9. Epub 2006 Dec 16. PMID 17180272
- BACKGROUNDGauderer MW, Ponsky JL, Izant RJ Jr. Gastrostomy without laparotomy: a percutaneous endoscopic technique. J Pediatr Surg. 1980 Dec;15(6):872-5. doi: 10.1016/s0022-3468(80)80296-x. PMID 6780678
- BACKGROUNDGiordano-Nappi JH, Ishioka S, Maluf-Filho F, Hondo FY, Matuguma SE, Sakai P. A new device for the introducer technique for percutaneous endoscopic gastrostomy placement. Endoscopy. 2007 Feb;39 Suppl 1:E274-5. doi: 10.1055/s-2007-966615. Epub 2007 Oct 24. No abstract available. PMID 17957639
- BACKGROUNDHiki N, Maetani I, Suzuki Y, Washizawa N, Fukuda T, Yamaguchi T; Tokyo Standard PEG Study Group. Reduced risk of peristomal infection of direct percutaneous endoscopic gastrostomy in cancer patients: comparison with the pull percutaneous endoscopic gastrostomy procedure. J Am Coll Surg. 2008 Nov;207(5):737-44. doi: 10.1016/j.jamcollsurg.2008.06.335. Epub 2008 Aug 9.