Head and Neck Neoplasms Clinical Trial
Official title:
Outpatient Percutaneous Radiologic Gastrostomy in Patients With Head and Neck Tumors
Verified date | March 2018 |
Source | Instituto Nacional de Cancer, Brazil |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 39 |
Est. completion date | November 21, 2018 |
Est. primary completion date | November 21, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Instituto Nacional do Cancer - HC1 | Rio de Janeiro |
Lead Sponsor | Collaborator |
---|---|
Instituto Nacional de Cancer, Brazil |
Brazil,
Campoli 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. — View Citation
Cantwell 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. — View Citation
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Foster 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. Epub 2006 Dec 16. — View Citation
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Hiki 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. — View Citation
Horiuchi A, Nakayama Y, Tanaka N, Fujii H, Kajiyama M. Prospective randomized trial comparing the direct method using a 24 Fr bumper-button-type device with the pull method for percutaneous endoscopic gastrostomy. Endoscopy. 2008 Sep;40(9):722-6. doi: 10.1055/s-2008-1077490. Epub 2008 Sep 4. — View Citation
Koide T, Inamori M, Kusakabe A, Uchiyama T, Watanabe S, Iida H, Endo H, Hosono K, Sakamoto Y, Fujita K, Takahashi H, Yoneda M, Tokoro C, Yasuzaki H, Goto A, Abe Y, Kobayashi N, Kubota K, Saito S, Nahajima A. Early complications following percutaneous endoscopic gastrostomy: results of use of a new direct technique. Hepatogastroenterology. 2010 Nov-Dec;57(104):1639-44. — View Citation
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Russell TR, Brotman M, Norris F. Percutaneous gastrostomy. A new simplified and cost-effective technique. Am J Surg. 1984 Jul;148(1):132-7. — View Citation
Rustom IK, Jebreel A, Tayyab M, England RJ, Stafford ND. Percutaneous endoscopic, radiological and surgical gastrostomy tubes: a comparison study in head and neck cancer patients. J Laryngol Otol. 2006 Jun;120(6):463-6. — View Citation
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Tucker AT, Gourin CG, Ghegan MD, Porubsky ES, Martindale RG, Terris DJ. 'Push' versus 'pull' percutaneous endoscopic gastrostomy tube placement in patients with advanced head and neck cancer. Laryngoscope. 2003 Nov;113(11):1898-902. — View Citation
Van Dyck E, Macken EJ, Roth B, Pelckmans PA, Moreels TG. Safety of pull-type and introducer percutaneous endoscopic gastrostomy tubes in oncology patients: a retrospective analysis. BMC Gastroenterol. 2011 Mar 16;11:23. doi: 10.1186/1471-230X-11-23. — View Citation
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Wilhelm SM, Ortega KA, Stellato TA. Guidelines for identification and management of outpatient percutaneous endoscopic gastrostomy tube placement. Am J Surg. 2010 Mar;199(3):396-9; discussion 399-400. doi: 10.1016/j.amjsurg.2009.08.023. — View Citation
Wollman B, D'Agostino HB. Percutaneous radiologic and endoscopic gastrostomy: a 3-year institutional analysis of procedure performance. AJR Am J Roentgenol. 1997 Dec;169(6):1551-3. — View Citation
* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Gastrostomy outcomes after the follow-up period. | Death for any reason using the gastrostomy tube, elective withdrawal after recovery of swallow function and persistence with gastrostomy tube. | Up to 24 weeks. | |
Primary | Complication rate. | Rate of other complications like bleeding, infection, cutaneous fistulae. | Up to 24 weeks. | |
Secondary | Duration of gastrostomy. | Duration of primary gastrostomy tube. | Up to 24 weeks. | |
Secondary | Technical success rate. | Gastrostomy tube insertion into gastric lumen. | Immediately. | |
Secondary | Procedure duration time. | Time necessary to place the gastrostomy tube, from gastric distention to local dressing. | Immediately after the procedure. | |
Secondary | Pain intensity. | Pain will be measured according to pain score (1-10). | Immediately after the procedure and during the total follow-up period - Up to 24 weeks. | |
Secondary | Additional procedures. | Procedures required after gastrostomy placement, like tube reinsertion or tube changes. | Up to 24 weeks. |
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