Prospective Evaluation of NOTES (Natural Orifice Translumenal Endoscopic Surgery) PEG "Rescue"

Malnutrition Clinical Trial

— PEGRescue  

Official title:

Prospective Evaluation of NOTES PEG "Rescue"

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01119040
• Other study ID #: 09-07-23
• Status: Terminated
• Phase: N/A
• First received: May 6, 2010
• Last updated: December 12, 2014
• Start date: November 2007
• Est. completion date: July 2010

Study information

• Verified date: December 2014
• Source: University Hospital Case Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine:

1. Utility of urgent upper endoscopy in setting of dislodges (percutaneous endoscopic gastrostomy) PEG tube.

2. Feasibility of replacing naive PEG tubes with Natural Orifice Translumenal Endoscopic Surgery (NOTES) in lieu of traditional surgical methods.

3. Efficacy of replacing naive PEG tubes with NOTES in lieu of traditional surgical methods.

Description:

1. Utility of Urgent Upper Endoscopy in Setting of Naïve Dislodged PEG Tubes as defined by:

• Percentage of Open vs. Closed Gastrotomy upon urgent endoscopy

• Presence of Incidental Pathology noted on Endoscopy

• Complications of Urgent Endoscopy

• Time of Procedure

2. Technical Feasibility of the NOTES procedure determined by:

• Number of Successful/Failed PEG Placements

• Number of Patients Requiring intra-operative conversion to laparotomy or laparoscopic procedure

• Time to Complete Procedure

• Presence or absence of post-procedural contrast extravasation on completion contrast radiographic study

3. Efficacy of NOTES PEG Rescue compared to historical controls as characterized by the following post-operative criteria:

• Number of Patients Requiring Subsequent Medical or Surgical Treatment for Intra-Abdominal Abscess

• Number of Patients Requiring Subsequent Medical or Surgical Wound Infection within 30 post-op days

• Post-Operative CT or Operative Findings consistent with abscess confirmed by culture positive drainage, aspiration

• Intra-Operative or Post-Operative Red Blood Cell Transfusion

• Length of Stay

• Antibiotics > 24h Post-Op

• 30 day Re-Admission

• Mortality

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria: Patients must meet ALL of the following criteria

• For prospective candidates, an initial attempt to pass a balloon tipped foley catheter through the external cutaneous tract into the stomach will be performed. It will then be followed by radiographic contrast study to evaluate for extravasation of contrast into the peritoneal cavity. If contrast is extravasated, this will be potential candidate for inclusion. If the foley catheter is unable to be passed through the cutaneous tract, that will also be considered someone for inclusion as this patient will still require an operative confirmation of the patency of the gastrotomy.

• For retrospective candidates, intra-operative confirmation of dislodged tube as reported in the medical record.

• The patient must demonstrate pre-operative hemodynamic and respiratory stability

• No overwhelming medical co-morbidities prohibitive of surgery

• Subject is 18 years of age or older

• Subject or subject's legal decision-making proxy agrees to participate, fully understands and signs the informed consent form

Exclusion Criteria: Patients must not meet ANY of the following criteria:

• Esophageal stricture prohibiting passage of an endoscope

• Any contraindication to surgery

• Pregnancy or actively breastfeeding women

• Evidence of active bowel obstruction

• Synchronous acute abdominal pathology warranting incision-based surgery

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malnutrition

Intervention

Procedure:
• Natural Orifice Translumenal Endoscopic Surgery
Natural Orifice Translumenal Endoscopic Surgery (NOTES) procedures involve transmural passage of flexible endoscopes introduced via a natural orifice whereby permitting access to the peritoneal cavity while avoiding skin incisions. No clear indication due to a number of physiologic, microbiologic, immunologic, and technical limitations. The concept of NOTES PEG "Rescue" in the setting of a dislodged naïve PEG tube may spare individual patients the physiologic stress of traditional surgery while concomitantly providing a natural segue to further study the NOTES platform in the human setting. PEG "Rescue" may represent a unique, practical, and empowering application of the burgeoning experience of natural orifice translumenal endoscopic surgery.

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Case Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Marks JM, Ponsky JL, Pearl JP, McGee MF. PEG "Rescue": a practical NOTES technique. Surg Endosc. 2007 May;21(5):816-9. Epub 2007 Apr 3. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Successful Replacements of Dislodged PEG Tubes With NOTES Procedures in Lieu of Traditional Surgical Methods.	Successful replacement will be determined via the number of patients requiring conversion from NOTES PEG rescue to conventional incision-based surgery.	30 day follow-up	Yes