Gastric FistulaNCT00835458
Endoscopic Treatment of Intestinal Fistulas and Perforations
A study testing gastro-gastric fistula closure in people with Gastric Fistula, run by Legacy Health System at 1 site in United States.
Trial summary
Background: T-shaped tissue anchors have promise to close incisions and perforations of the intestines securely. The closure of perforations, gastro-gastric, or intestinal fistulas usually requires invasive open or laparoscopic surgery under general anesthesia and can be complex surgeries due to their reoperative or… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gastric Fistula
- What is being tested?
- gastro-gastric fistula closure
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to undergo general anesthesia
- Age > 18 yrs. of age and < 85 yrs. of age
- Ability to give informed consent
Who cannot join
- Contraindicated for esophagogastroduodenoscopy (EGD)
- Contraindicated for colonoscopy
- BMI < 40
- Presence of esophageal stricture
- Altered gastric anatomy
- Intraabdominal abscess or severe inflammation
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Good Samaritan Hospital, Legacy Health System
Portland, Oregon, 97210
About this study
Official title: Closure of Fistulas and Perforations Endoscopically to Avoid Laparoscopic or Open Surgery
Background: T-shaped tissue anchors have promise to close incisions and perforations of the intestines securely. The closure of perforations, gastro-gastric, or intestinal fistulas usually requires invasive open or laparoscopic surgery under general anesthesia and can be complex surgeries due to their reoperative or inflammatory nature.
Objective: The proposed use of full thickness tissue anchors adds a new surgical aspect to the endoscopic treatment of fistulas and perforations by offering a robust suture like closure of defects. Instead of a 20 cm abdominal incision or 3 or 4 one centimeter incisions with the related postoperative morbidity an endoscopic technique is used which requires no postoperative limitation of activities.
Read more
Methods: In this study the investigators propose to use an endoscopic technique that eliminates the need for open or laparoscopic surgery and provides a more robust endoscopic repair than is possible with traditional endoscopic tools. Patients who are scheduled to undergo surgery for intestinal fistulas will be screened for study eligibility. Patients who are scheduled to undergo complex polypectomy, or submucosal dissection will be screened for study eligibility and informed about all possible therapies in case of an iatrogenic perforation (open - laparoscopic surgery, endoscopic clipping, endoscopic closure with tissue anchors). A commercially available flexible endoscope will be inserted through the mouth and the fistula or perforation will be closed using the Tissue Approximation System (Ethicon Endo Surgery, Cincinnati, OH).
The investigators will initially evaluate the potential benefit, risks and impact on the patient's quality of life of this modified surgical technique in 5 patients.
Expected results: The potential advantages to the patients entered into this study result from the avoidance of open or laparoscopic surgery with the related risks (bleeding, injury of organs, post operative wound infection, hernia), shorter hospital stay, reduced postoperative pain, earlier return to work, and cosmetic advantage.
- Conditions
- Gastric Fistula
- Being tested
- gastro-gastric fistula closure
- Keywords
- gastric fistula, perforation, endoscopy, closure, endolumenal
- Medical subject headings
- Gastric Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastro-gastric fistula closureProcedure or surgery
Also called Tissue Apposition System, TAS, 510(k) approval # K070151
The mucosa surrounding the orifice of the fistula will be ablated using standard endoscopic techniques. Remnants of mucosa will be treated with argon-plasma coagulation. The mucosa free orifice of the fistula will be closed using the Tissue Apposition System. Tissue anchors with attached threads will be deployed through the intestinal wall full thickness using delivery needles through the working channel of the endoscope. After two anchors are deployed on both sides of the fistulas' orifice a knotting element will be cinched down to approximate the two sides of the fistulas' orifice. The procedure will be repeated until the fistulas' orifice is securely closed.
What is being measured
The primary outcome is the main question the study is designed to answer.
fistula or perforation closure possible; yes or no
Measured: day of surgery
Secondary outcomes (2)
fistula stays closed after 6 months
Measured: 6 months
quality of life comparison, pre-op and after 6 months post-op
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionOct 2009 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastric FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Legacy Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon Endo-Surgery
- Investigators
- Lee L Swanstrom, MD, FACS, Principal investigator, Legacy Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00835458
- Sponsor's protocol ID
- IIS GRANT#25206
- Status last verified
- Feb 2009
- First submitted
- 2 Feb 2009
- Last updated
- 11 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Sumiyama K, Gostout CJ, Rajan E, Bakken TA, Deters JL, Knipschield MA. Endoscopic full-thickness closure of large gastric perforations by use of tissue anchors. Gastrointest Endosc. 2007 Jan;65(1):134-9. doi: 10.1016/j.gie.2006.01.050.
PubMed 17185093Raju GS, Fritscher-Ravens A, Rothstein RI, Swain P, Gelrud A, Ahmed I, Gomez G, Winny M, Sonnanstine T, Bergstrom M, Park PO. Endoscopic closure of colon perforation compared to surgery in a porcine model: a randomized controlled trial (with videos). Gastrointest Endosc. 2008 Aug;68(2):324-32. doi: 10.1016/j.gie.2008.03.006. Epub 2008 Jun 17.
PubMed 18561931Sporn E, Miedema BW, Bachman SL, Astudillo JA, Loy TS, Calaluce R, Thaler K. Endoscopic colotomy closure after full thickness excision: comparison of T fastener with multiclip applier. Endoscopy. 2008 Jul;40(7):589-94. doi: 10.1055/s-2008-1077377.
PubMed 18609453Bergstrom M, Swain P, Park PO. Early clinical experience with a new flexible endoscopic suturing method for natural orifice transluminal endoscopic surgery and intraluminal endosurgery (with videos). Gastrointest Endosc. 2008 Mar;67(3):528-33. doi: 10.1016/j.gie.2007.09.049.
PubMed 18294516
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closure of Fistulas and Perforations Endoscopically to Avoid Laparoscopic or Open Surgery
- ClinicalTrials.gov ID
- NCT00835458
- Acronym / sponsor ID
- IIS GRANT#25206
- Conditions
- Gastric Fistula
- Keywords
- gastric fistula, perforation, endoscopy, closure, endolumenal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Legacy Health SystemUniversity, hospital or other
- Collaborators
- Ethicon Endo-Surgery
- Study start
- Feb 2009
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 3 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: T-shaped tissue anchors have promise to close incisions and perforations of the intestines securely. The closure of perforations, gastro-gastric, or intestinal fistulas usually requires invasive open or laparoscopic surgery under general anesthesia and can be complex surgeries due to their reoperative or inflammatory nature.
Objective: The proposed use of full thickness tissue anchors adds a new surgical aspect to the endoscopic treatment of fistulas and perforations by offering a robust suture like closure of defects. Instead of a 20 cm abdominal incision or 3 or 4 one centimeter incisions with the related postoperative morbidity an endoscopic technique is used which requires no postoperative limitation of activities.
Methods: In this study the investigators propose to use an endoscopic technique that eliminates the need for open or laparoscopic surgery and provides a more robust endoscopic repair than is possible with traditional endoscopic tools. Patients who are scheduled to undergo surgery for intestinal fistulas will be screened for study eligibility. Patients who are scheduled to undergo complex polypectomy, or submucosal dissection will be screened for study eligibility and informed about all possible therapies in case of an iatrogenic perforation (open - laparoscopic surgery, endoscopic clipping, endoscopic closure with tissue anchors). A commercially available flexible endoscope will be inserted through the mouth and the fistula or perforation will be closed using the Tissue Approximation System (Ethicon Endo Surgery, Cincinnati, OH).
The investigators will initially evaluate the potential benefit, risks and impact on the patient's quality of life of this modified surgical technique in 5 patients.
Expected results: The potential advantages to the patients entered into this study result from the avoidance of open or laparoscopic surgery with the related risks (bleeding, injury of organs, post operative wound infection, hernia), shorter hospital stay, reduced postoperative pain, earlier return to work, and cosmetic advantage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability to undergo general anesthesia
- Age > 18 yrs. of age and < 85 yrs. of age
- Ability to give informed consent
Key exclusion criteria (7 listed)
- Contraindicated for esophagogastroduodenoscopy (EGD)
- Contraindicated for colonoscopy
- BMI < 40
- Presence of esophageal stricture
- Altered gastric anatomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gastro-gastric fistula closureAlso: Tissue Apposition System, TAS, 510(k) approval # K070151The mucosa surrounding the orifice of the fistula will be ablated using standard endoscopic techniques. Remnants of mucosa will be treated with argon-plasma coagulation. The mucosa free orifice of the fistula will be closed using the Tissue Apposition System. Tissue anchors with attached threads will be deployed through the intestinal wall full thickness using delivery needles through the working channel of the endoscope. After two anchors are deployed on both sides of the fistulas' orifice a knotting element will be cinched down to approximate the two sides of the fistulas' orifice. The procedure will be repeated until the fistulas' orifice is securely closed. | Procedure or surgery | – |
Primary outcome
fistula or perforation closure possible; yes or no
Time frame: day of surgery
2 secondary outcomes
fistula stays closed after 6 months
Time frame: 6 months
quality of life comparison, pre-op and after 6 months post-op
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2009.
- Background: PubMed 17185093Sumiyama K, Gostout CJ, Rajan E, Bakken TA, Deters JL, Knipschield MA. Endoscopic full-thickness closure of large gastric perforations by use of tissue anchors. Gastrointest Endosc. 2007 Jan;65(1):134-9. doi: 10.1016/j.gie.2006.01.050.
- Background: PubMed 18561931Raju GS, Fritscher-Ravens A, Rothstein RI, Swain P, Gelrud A, Ahmed I, Gomez G, Winny M, Sonnanstine T, Bergstrom M, Park PO. Endoscopic closure of colon perforation compared to surgery in a porcine model: a randomized controlled trial (with videos). Gastrointest Endosc. 2008 Aug;68(2):324-32. doi: 10.1016/j.gie.2008.03.006. Epub 2008 Jun 17.
- Background: PubMed 18609453Sporn E, Miedema BW, Bachman SL, Astudillo JA, Loy TS, Calaluce R, Thaler K. Endoscopic colotomy closure after full thickness excision: comparison of T fastener with multiclip applier. Endoscopy. 2008 Jul;40(7):589-94. doi: 10.1055/s-2008-1077377.
- Background: PubMed 18294516Bergstrom M, Swain P, Park PO. Early clinical experience with a new flexible endoscopic suturing method for natural orifice transluminal endoscopic surgery and intraluminal endosurgery (with videos). Gastrointest Endosc. 2008 Mar;67(3):528-33. doi: 10.1016/j.gie.2007.09.049.
- Evaluation of an Endoscopic Suturing System for Tissue Apposition in Colonic PolypectomyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee L Swanstrom, MD, FACS principal investigator
Legacy Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gastro-gastric fistula closure in people with Gastric Fistula, run by Legacy Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fistula or perforation closure possible; yes or no (time frame: day of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00835458, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2009.