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Fistula clinical trials

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NCT ID: NCT01868984 Terminated - Fistula Stenosis Clinical Trials

Paclitaxel for the Treatment of Upper-Extremity Arteriovenous Access Fistula Stenosis

PaciFIST-1
Start date: May 2013
Phase: Phase 2
Study type: Interventional

The objective of this study is to evaluate the safety and effectiveness of the use of intravascular paclitaxel, in addition to standard therapy, for the treatment of arteriovenous dialysis access fistula stenosis. A fistulogram will be performed in standard fashion. The diagnostic component will include evaluation of the inflow artery, arterial anastomosis and full length of the fistula vein or graft, plus venous return up to the heart. The location, vessel size, lesion diameter and percent stenosis for each lesion will be recorded. Enrollment and randomization will occur at this point. All patients will then receive standard therapy for their stenosis. This will include intravenous heparin administered in a standard dose of 70 units/kg. Lesions that respond poorly to angioplasty (>30% residual stenosis after angioplasty treatment with 2 inflations) will be stented. Stent selection will be based on clinical setting. Initial stent treatment will utilize an uncovered nitinol stent. Treatment of in-stent restenosis will include initial balloon angioplasty, and use of a covered stent (Viabahn, GORE, or Fluency, Bard). Documentation of location and type of treatment for each lesion treated will be recorded. Once standard treatment is completed, the operating surgeon will be informed of the patient randomization: treatment (paclitaxel) or control. For subjects assigned to treatment, Paclitaxel solution treatment of each lesion encountered from proximal to distal will be attempted until the 20 mg Paclitaxel dose limit is met. A TAPAS infusion catheter will be used for all paclitaxel dose administrations. The TAPAS infusion catheter will be positioned to reduce the presence of branches which permit the loss of paclitaxel from the treatment zone. After the full outflow vein segment is treated, the fistulogram is completed in the standard fashion. Prior to removal of the sheath, a final angiographic study of all areas treated is performed to document patency and lesion appearance. For the control group, instead of paclitaxel administration, a sham treatment period of 10 minutes is allowed to elapse followed by the performance of the final completion angiogram. Any additional lesions identified with this study are then treated appropriately following standard technique. All patients will follow the same follow up evaluation schedule.

NCT ID: NCT01864473 Completed - Vaginal Fistula Clinical Trials

Management of Vaginal Fistula by Kshar Sutra, a Minimally Invasive Treatment

Bhagandar
Start date: October 2010
Phase: N/A
Study type: Interventional

Background:Fistula-in-ano is described as Bhagandara in the classics of Ayurveda, is an ancient surgical problem. It was commonly described even in the Vedic period. The description of Bhagandara, with the full text of its managements, can be gathered from the Sushruta Samhita, which is supposed to have been written in the second century B.C. Fistula-in-ano is a tubular ulcer formed around the peri-anal region. It may also be found anywhere in the perineal region. Its ramifications can extend to the lower back, subscrotal region, vagina etc. Hypothesis:In Sushruta Samhita(2nd BC) Acharya Sushruta has advocated Kshar Sutra treatment due to probability of recurrence after surgery. The present treatment modality Kshar Sutra has been found effective and as adjuvant therapy by avoiding recurrence.

NCT ID: NCT01863914 Completed - Diabetes Mellitus Clinical Trials

Vascular Protective Effect of Rosuvastatin in Arteriovenous Fistula

Start date: November 2012
Phase: Phase 2
Study type: Interventional

Background Arteriovenous (AV) fistula is the most common vascular access for long-term hemodialysis in the end-stage renal disease (ESRD) patients. About 25% of these patients are diabetes mellitus. However, the effects of hyperglycemia on the vascular function of arteriovenous fistula are still remained unclear. Studies have shown that blood flow in the AV fistula is significantly reduced in patients with diabetes mellitus. Diabetic patients also require a longer period of time for the maturation of AV fistula, and have slightly higher complication rate than non-diabetic patients. Statins have been widely shown to mediate several important pleiotropic effects in the improvement of vascular endothelial dysfunction, attenuation of inflammatory responses, stabilization of atherosclerotic plaques, inhibition of vascular smooth muscle proliferation, and modulation of procoagulant activity and platelet function.Our experimental studies in diabetic animals demonstrate that administration of a water-soluble statin rosuvastatin significantly improves the fistula flow, vascular function and luminal dilatation of AV fistula in diabetic rats by suppression of vascular oxidative stress and inflammatory load. Study hypothesis The central hypothesis of this research project is rosuvastatin mediates pleiotropic protective effect on vascular endothelial function and suppresses the regional pro-inflammatory reaction in the vasculature, therefore administration of rosuvastatin during the perioperative period of creation of native AV fistulas in diabetic patients with ESRD may potentiate the vascular function and reduce the primary failure rate of AV fistulae.

NCT ID: NCT01847612 Recruiting - Liver Disease Clinical Trials

Use of Indocyanine Green Cholangiography and Methylene Blue to Detect Postoperative Biliary Fistula After Hepatectomy

CAMFIB
Start date: July 8, 2013
Phase: Phase 3
Study type: Interventional

The aim of the present study is to evaluate whether the use of indocyanine green fluorescent cholangiography is responsible in a decrease of biliary fistula's rate in patients with liver diseases requiring liver resection.

NCT ID: NCT01828892 Recruiting - Clinical trials for Low-output External Gastrointestinal Fistula

Glue Application in the Treatment of Low-Output Fistulas

FG-treatment
Start date: March 2014
Phase: N/A
Study type: Interventional

Adjuvant use of fibrin glue (FG) in the fistula tract has been shown to promote closure of low-output enterocutaneous fistulas (ECFs). The primary objectives of this study are to compare the clinical efficacy, safety of autologous platelet-rich fibrin glue (PRFG), commercial fibrin glue, and control therapy in the management of patients with low-output volume ECFs.

NCT ID: NCT01828190 Completed - Crohn's Disease Clinical Trials

The Influence of Hyperbaric Oxygen in Patients With Perianal Crohn's Disease Already Treated With TNF Alpha Blockers Treated With TNF Alpha Blockers

Start date: March 2013
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on patient suffering from residual Crohn's disease related perianal fistulas already treated with TNF alpha blockers

NCT ID: NCT01806545 Completed - Clinical trials for Arteriovenous Fistula

An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Creation of an Arteriovenous Fistula to Facilitate Hemodialysis Access

Start date: March 26, 2013
Phase: Phase 2
Study type: Interventional

A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard practice treatment in improving the rate of AVF maturation and use in subjects with end-stage renal disease undergoing surgery for creation of an AVF to facilitate hemodialysis access. It is hypothesized that when placed outside the blood vessel, the seeded SRM003 gelatin matrix containing endothelial cells can provide a continuous supply of multiple growth regulatory compounds to the underlying cells within the blood vessel, while being protected from the effects of blood flow in the vessel(s) or complications resulting from being in direct contact with the point of injury.

NCT ID: NCT01803347 Completed - Anal Fistula Clinical Trials

Clinical Trial to Evaluate the Efficacy and Safety of Stem Cells

FISPAC
Start date: February 2013
Phase: Phase 3
Study type: Interventional

Efficacy of treatment of perianal fistula with mesenchymal stem cells and surgery

NCT ID: NCT01755260 Recruiting - Clinical trials for Closure of POPF After Pancreaticoduodenectomy

Route of Nutritional Support for Pancreatic Fistula

Start date: September 2013
Phase: N/A
Study type: Interventional

The aim of this study is to compare the closure rate of pancreatic fistula (PF) after pancreaticoduodenectomy (PD) under various types of nutrition.

NCT ID: NCT01748422 Recruiting - Neuropathic Pain Clinical Trials

Qutenza (Topical Capsaicin 8%) for Painful Arteriovenous Fistulae

Start date: November 2015
Phase: N/A
Study type: Observational

Arteriovenous fistulae are artificial connections between the artery and vein in the arm which allow needles to be inserted for haemodialysising patients wit kidney failure. Occasionally severe debilitating pain can arise from these fistulae for which no cause can be found. Such pain can be very difficult to treat. Many commonly used used painkillers are known to cause significant side effects in patients with renal failure (drowsiness, confusion etc. Qutenza (topical capsaicin 8%) is a new treatment made from chilli peppers which is applied to the skin as a patch and works directly at the nerve endings in the skin to prevent pain. It therefore should not have the systemic side effects of other drugs. It has been demonstrated to be beneficial in other painful conditions for example post-shingles pain and nerve pain from HIV. It has never been used for critical ischaemia before. We propose to investigate the efficacy of Qutenza in treating patients with end stage renal failure and chronic pain from their fistulae (AVF). We will recruit 20 patients with painful AVF and treat them with Qutenza. We will follow them up for 12 weeks and monitor the change in their pain scores.