Outpatient Percutaneous Radiologic Gastrostomy in Patients With Head and Neck Tumors
NCT ID: NCT03252509
Last Updated: 2021-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
39 participants
INTERVENTIONAL
2017-03-20
2018-11-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Prospective Study of Prophylactic Gastrostomy in Head and Neck Cancer Patients Undergoing Chemoradiotherapy
NCT01876693
Preoperative Concurrent Chemoradiotherapy for Locally Advanced Gastroesophageal Junction or Upper Gastric Adenocarcinoma
NCT02193594
Disease Outcomes and Toxicities in Patients With Gastrointestinal and Sarcomatous Malignancies
NCT05743426
RT for Cervical Adenocarcinoma/adenosquamous Carcinoma
NCT06741046
Use of Positron Emission Tomography/Computed Tomography (PET/CT) to Assess Tumor Response to Neoadjuvant Treatment for Distal Rectal Cancer
NCT00254683
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Nowadays it is considered as the first line procedure to prolonged enteral access on this patients.
The indications to perform a percutaneous gastrostomy in a cancer center are usually related to head and neck, central nervous system and esophagus tumors. In our institution around 80% of the percutaneous gastrostomy are performed in patients with head an neck tumors.
Although percutaneous gastrostomy is considered a safe procedure, there are some complications related, specially in oncologic patients. Those complications are reported in about 40% of the cases.
Percutaneous gastrostomy is usually performed as a inpatient procedure, which leads to hospitalization costs. However, some studies have shown that is safe and viable to perform percutaneous gastrostomy (both endoscopic or radiologic), as a outpatient procedure, in patients with head a neck tumors.
As both techniques (endoscopic and radiologic) present similar results, patients treated in our institution that require a percutaneous gastrostomy are referred to endoscopic and interventional radiology departments.
Some of these patients are selected to undergo an outpatient procedure, based on social and clinical criteria.
The majority of the available data shows that both the endoscopic and the radiologic techniques present similar results in terms of security and rate of precocious and late complications, and that both are superior than the surgical technique, considering they are least invasive and related with lower rates of complication and costs.
In the present, the traction (Gauderer-Ponsky) technique is the most widely used in our institution for the endoscopic procedure.
In the interventional radiology department the percutaneous gastrostomy is performed using the introduction (Russel) technique, in which a guidewire is positioned after the stomach needle puncture, made under ultrasound or fluoroscopic guidance. After that, the tract is progressively dilated to allow the introduction of the gastrostomy balloon catheter, through the abdominal wall, using a peel-away sheath.
This same technique can be performed for the endoscopic gastrostomy, using the same gastrostomy kit, but under endoscopic guidance.
Some authors suggest that the introduction technique, although more challenging, is associated with less stoma infections, because is the only one that is not associated with oral catheterization.
For the patients with head an neck tumors, there is also a reduced risk of metastases implants on the puncture site.
Besides those considerations, the data available is still not consensual.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Percutaneous radiologic gastrostomy.
Outpatient percutaneous radiologic gastrostomy in patients with head and neck tumors before, during or after the oncologic treatment.
Percutaneous radiologic gastrostomy
Percutaneous radiologic gastrostomy: Under conscious sedation and local analgesia, the ultrasound is performed to determine abdominal structures. The stomach is distended using room air through a nasogastric catheter or a 5 French (Fr) catheter. Gastropexy is performed under fluoroscopic guidance. The stomach is accessed using a 18 gauge (G) needle. Guidewire is advanced to the stomach. Progressive tract dilatations until the size of the gastrostomy tube is achieved. The catheter is advanced through the peel-away sheath. The catheter's balloon is inflated with 10ml of distilled water. Iodine contrast is injected to confirm position. After the procedure, the patient is observed for 3 hours. If there are no complications, the patient is discharged.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Percutaneous radiologic gastrostomy
Percutaneous radiologic gastrostomy: Under conscious sedation and local analgesia, the ultrasound is performed to determine abdominal structures. The stomach is distended using room air through a nasogastric catheter or a 5 French (Fr) catheter. Gastropexy is performed under fluoroscopic guidance. The stomach is accessed using a 18 gauge (G) needle. Guidewire is advanced to the stomach. Progressive tract dilatations until the size of the gastrostomy tube is achieved. The catheter is advanced through the peel-away sheath. The catheter's balloon is inflated with 10ml of distilled water. Iodine contrast is injected to confirm position. After the procedure, the patient is observed for 3 hours. If there are no complications, the patient is discharged.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Instituto Nacional de Cancer, Brazil
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hugo R Gouveia
Role: PRINCIPAL_INVESTIGATOR
Instituto Nacional do Câncer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Instituto Nacional do Cancer - HC1
Rio de Janeiro, , Brazil
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Cosentini 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.
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. doi: 10.1007/s00464-006-9068-9. Epub 2006 Dec 16.
Gauderer 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.
Giordano-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.
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.
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.
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.
Kusaka K, Itoh T, Kawaura K, Yamakawa J, Takahashi T, Kanda T. Three-point fixation of stomach to abdominal wall in the percutaneous endoscopic gastrostomy procedure. Endoscopy. 2005 May;37(5):494. doi: 10.1055/s-2005-861233. No abstract available.
Maetani I, Tada T, Ukita T, Inoue H, Sakai Y, Yoshikawa M. PEG with introducer or pull method: a prospective randomized comparison. Gastrointest Endosc. 2003 Jun;57(7):837-41. doi: 10.1016/s0016-5107(03)70017-0.
de Souza e Mello GF, Lukashok HP, Meine GC, Small IA, de Carvalho RL, Guimaraes DP, Mansur GR. Outpatient percutaneous endoscopic gastrostomy in selected head and neck cancer patients. Surg Endosc. 2009 Jul;23(7):1487-93. doi: 10.1007/s00464-009-0381-y. Epub 2009 Mar 5.
Russell TR, Brotman M, Norris F. Percutaneous gastrostomy. A new simplified and cost-effective technique. Am J Surg. 1984 Jul;148(1):132-7. doi: 10.1016/0002-9610(84)90300-3.
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. doi: 10.1017/S0022215106000661.
Sacks BA, Vine HS, Palestrant AM, Ellison HP, Shropshire D, Lowe R. A nonoperative technique for establishment of a gastrostomy in the dog. Invest Radiol. 1983 Sep-Oct;18(5):485-7. doi: 10.1097/00004424-198309000-00015.
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. doi: 10.1097/00005537-200311000-00007.
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.
Walton GM. Complications of percutaneous gastrostomy in patients with head and neck cancer--an analysis of 42 consecutive patients. Ann R Coll Surg Engl. 1999 Jul;81(4):272-6.
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.
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. doi: 10.2214/ajr.169.6.9393163.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
INCA RI
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.