Outpatient Percutaneous Radiologic Gastrostomy in Patients With Head and Neck Tumors

NCT03252509 | Completed

• 1 other identifier: INCA RI
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Gastrostomy; Head and Neck Neoplasms; Malignant Neoplasm

Keywords

percutaneous radiologic gastrostomy; Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (1)

• Complication rate.

  Rate of other complications like bleeding, infection, cutaneous fistulae.

  Up to 24 weeks.

Secondary Outcomes (5)

• Duration of gastrostomy.

  Up to 24 weeks.

• Technical success rate.

  Immediately.

• Procedure duration time.

  Immediately after the procedure.

• Pain intensity.

  Immediately after the procedure and during the total follow-up period - Up to 24 weeks.

• Additional procedures.

  Up to 24 weeks.

Other Outcomes (1)

• Gastrostomy outcomes after the follow-up period.

  Up to 24 weeks.

Study Arms (1)

Percutaneous radiologic gastrostomy.

EXPERIMENTAL

Outpatient percutaneous radiologic gastrostomy in patients with head and neck tumors before, during or after the oncologic treatment.

Procedure: Percutaneous radiologic gastrostomy

Interventions

Percutaneous radiologic gastrostomy PROCEDURE

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.

Percutaneous radiologic gastrostomy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• patients who live more than one hour away from the hospital, coagulopathies, refuse to join the protocol.

Sponsors & Collaborators

• Instituto Nacional de Cancer, Brazil: lead

Study Sites (1)

Instituto Nacional do Cancer - HC1

Rio de Janeiro, 20.231-092, Brazil

Location

Related Publications (20)

• 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.

  PMID: 19558672 BACKGROUND

• 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.

  PMID: 18375303 BACKGROUND

• 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.

  PMID: 9790204 BACKGROUND

• 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.

  PMID: 17180272 BACKGROUND

• 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.

  PMID: 6780678 BACKGROUND

• 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.

  PMID: 17957639 BACKGROUND

• 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.

  PMID: 18954787 BACKGROUND

• 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.

  PMID: 18773341 BACKGROUND

• 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.

  PMID: 21443135 BACKGROUND

• 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.

  PMID: 15844032 BACKGROUND

• 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.

  PMID: 12776029 BACKGROUND

• 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.

  PMID: 19263126 BACKGROUND

• 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.

  PMID: 6430111 BACKGROUND

• 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.

  PMID: 16772054 BACKGROUND

• 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.

  PMID: 6642944 BACKGROUND

• 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.

  PMID: 14603043 BACKGROUND

• 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.

  PMID: 21410958 BACKGROUND

• 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.

  PMID: 10615198 BACKGROUND

• 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.

  PMID: 20226918 BACKGROUND

• 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.

  PMID: 9393163 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site

Study Officials

• Hugo R Gouveia

  Instituto Nacional do Câncer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Pre a post interventional study, in patients with head and neck neoplasms, eligible for an outpatient procedure.

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 17, 2017
• Study Start: March 20, 2017
• Primary Completion: November 21, 2018
• Study Completion: November 21, 2018
• Last Updated: April 13, 2021

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)