Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Hemorrhage

Neoplasm Metastasis

Colorectal Neoplasms

Gastrointestinal Hemorrhage

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Natriuretic Agents

Coagulants

All Drugs and Chemicals

Vasoconstrictor Agents

Amino Acids

Deamino Arginine Vasopressin

Vasopressins

Arginine Vasopressin

Hemostatics

Arginine

Four dose levels and two dosing schedules with 3 patients in each group.

Dose groups: Group 1: 0.25 µg/kg/day; Group 2: 0.25 µg/kg/12 hours; Group 3: 0.50 µg/kg/12 hours; Group 4: 1 µg/kg/day; Group 5: 1 µg/kg/12 hours; Group 6: 2 µg/kg/day.

All groups will receive desmopressin intravenously, in a 15-20 minutes infusion, one or two times a day. The administration will be repeated 24 hours after the first infusion.

Desmopressin

Enrique Roca, MD

The objective of this study is to find the maximum tolerated dose and preliminary efficacy of desmopressin as an haemostatic agent, when is administered to patients with colorectal cancer and rectal bleeding, before specific oncologic treatment with surgery and/or chemotherapy and/or radiotherapy.

Colorectal cancer is the third cause of cancer in men and women, according to data recently published in the United Sates, and the third cause of death in the same population. Ninety percent (90%) of patients have symptoms at the time of diagnosis, being rectal bleeding the most frequent one (50% of cases). Bleeding, mainly mild or moderate, has no specific treatment, and during the staging of the disease, can not be controlled.

Desmopressin, a synthetic analogue of vasopressin, is a selective agonist of the receptor V2 of vasopressin, inducing, among others, an haemostatic effect. Interestingly, the expression of this receptor has been described in human gastrointestinal tract, including colon and rectum and in colorectal tumors. Moreover, desmopressin has shown a significant antitumor activity in preclinical murine models of colorectal cancer.

This is a dose finding study, to investigate a new indication of desmopressin as an haemostatic agent in patients with colorectal cancer with mild to moderate rectal bleeding.

Desmopressin (DDAVP) in Patients With Colorectal Cancer and Rectal Bleeding

Prospective, Open-labelled, Phase II Study, of the Administration of Desmopressin in Patients With Colorectal Cancer, With or Without Metastasis, With Rectal Bleeding, Before Treatment With Surgery and/or Chemotherapy and/or Radiotherapy.

A total of 6 groups with 3 patients each, with different dose ranges and dosing schedules will be assessed.

The number of patients in each group with grade 3 or 4 adverse events, including clinical or analytical findings, will be determined in order to stablish the maximum tolerated dose.

Once the maximum tolerated dose is determined, other 12 patients will be assessed to evaluate safety and tolerability of the study drug when administered as monotherapy.

Clinical endpoints such us rectal bleeding, mucorrhea, evacuatory attempts and rectal pain will be assessed before and after treatment with the study drug.

Response will be classified as complete or partial response.

Laboratorio Elea Phoenix S.A.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Pelvic Neoplasms

Proctitis

Gastroenteritis

Procedure using the HALO90 Ablation catheter to heat a thin layer of rectal tissue using radiofrequency to reduce inflammation and bleeding in subjects with radiation proctitis.

FDA approved endoscopic device for use in coagulation of tissue in the digestive tract using radiofrequency energy.

HALO90 Ablation catheter

Jeffrey M. Marks, MD

This study involves evaluating a procedure in which the study device, the HALO90 Ablation catheter, is used to heat a thin layer of tissue lining the rectum using radiofrequency (RF) energy in subjects suffering from radiation proctitis (acute inflammation of the inner lining of the rectum caused by the side effects of radiation treatments that can lead to bleeding).

In medical procedures, the RF energy used with this device, has been historically used in shrinking or removing soft-tissue, for surgical cutting, and for stopping bleeding. The device is cleared by the Food and Drug Administration (FDA) for use in coagulation (to assit with stoping bleeding and clotting of blood) of tissue within the digestive tract. The device has been used in areas outside the esophagus (inner lining of the throat), including the rectum to treat radiation proctitis. The stoppage of bleeding of radiation proctitis, using the HALO device, may be one method to control the bleeding.

The purpose of this study is to evaluate the effectiveness and record the results of treatment of radiation proctitis using the HALO device.

This study is intended to prospectively gather information regarding the performance of an endoscope-mounted radiofrequency (RF) energy device, which utilizes RF energy for the coagulation of gastrointestinal tissue in the setting of bleeding of radiation proctitis. The study device, the HALO90 Ablation catheter, has an FDA 510(k) clearance for human use.

The study design is a single-site, prospective clinical trial to gather performance data regarding a 510(k)-cleared, endoscopically-guided radiofrequency energy ablation device for the coagulation of hemorrhagic radiation proctitis.

Study subjects will have experienced bloody stools due to proctitis following pelvic radiation for cancers of the prostate or uterine endometrium. The study will include female and male adult patients who have received pelvic radiotherapy for such indications as cancer of the prostate or endometrium and have subsequently experienced recurrent hemorrhagic radiation proctitis.

As part of this protocol, focal areas of the epithelial lining of the diseased colon, rectum, and/or anus will be treated with the study device. The aim is to obtain information about the hemostatic effect of this device. The treatment settings evaluated in this study have been previously established with this device in the esophagus in "treat and resect" protocols, as well as in clinical trials for Barrett's esophagus with long-term follow-up.

Treatment of Hemorrhagic Radiation Proctitis Using the Halo System

As this is a feasibility trial, the plan is to evaluate safety and efficacy in relation to adverse events in a small population (20 max) of patients.

Covidien, GI Solutions

University Hospitals Cleveland Medical Center

Principal Investigator

Ablation Catheter

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Jeffrey Marks, MD

Subjects with radiation proctitis who met inclusion criteria

Ablation Treatment

There was no analysis of the data. Feasibility study with only one subject enrolled

Number of Participants With Adverse Events

Overall Study

Skin and Connective Tissue Diseases

Hernia

Pressure Ulcer

Diverticulitis

Rectal Neoplasms

Diverticulum

Diverticular Diseases

The digital rectal examination is performed in lateral decubitus i.e. curled up position . The patient in left lateral decubitus if the examiner is right handed and right lateral decubitus if the examiner is left handed.

The digital rectal examination is performed supine, spread legs, feet on the examination table. The examiner is in the patient's right side if he is right handed and in the patient's left side if he is left-handed.

lateral decubitus

supine decubitus

Digital rectal examination is an act clinically performed daily by physicians and surgeons. It remains the key diagnostic test and directs the therapeutic management of cancer of the lower and middle rectum. It can be done in two main positions: lateral decubitus, and supine.

However, no randomized study in colorectal surgery is not interested in evaluating the best position to perform a full rectal exam.

Informativeness to Digital Rectal Examination

Prospective Randomized Study Comparing the Results of Digital Rectal Examination in the Supine and Lateral Decubitus

Full digital rectal examination is defined by a rectal examination for investigating the superior pole of the prostate, to examine the entire circumference and the rectal sphincter.

This score assesses the sphincter tone at rest and during exercise. This score classes the sphincter tone in both situations: tone undetectable (score = 0) to hypertonic sphincter that does not allow the introduction of a finger (score = 5)

This analysis aims to determine what information is missing most often in one group compared to another (height to digital rectal examination, circumference of the digital rectal examination , assessment of sphincter tone)

the conversion rate decided by the examiner corresponds to the switch from one position to another

After the digital rectal examination, the examiner shows the patient a picture of the two positions and ask him the question: which position is the most embarrassing?

Centre Hospitalier Universitaire, Amiens

Conformal three-dimensional radiotherapy to deliver to the primary tumor and the enlarged pelvic nodes a total dose of 39Gy in 13 sessions of 3Gy in 17 days.

rectal cancer radiotherapy

Joan Lozano, MD

Many patients with rectal cancer were not candidates for surgical resection because advanced age, comorbidities, or multiple synchronous metastases. In this scenario only comfort measures or different palliative radiotherapy regimens are applied, from single doses to treatments lasting several weeks. The aim of this prospective study is to describe the preliminary results of our protocol of hypofractionated palliative radiotherapy in patients with non-operable rectal cancer.

Many patients with rectal cancer were not candidates for surgical resection because advanced age, comorbidities, or multiple synchronous metastases. In this scenario only comfort measures or different palliative radiotherapy regimens are applied, from single doses to treatments lasting several weeks. The aim of this prospective study is to describe the preliminary results of our protocol of hypofractionated palliative radiotherapy in patients with non-operable rectal cancer.

Patients with rectal cancer who were not candidates for surgical resection because advanced age, comorbidities, or multiple synchronous metastases at the time of diagnosis were considered eligible.

Patients were immobilized in the prone position with a belly-board in order to reduce small bowel irradiation. To limit organ motion patient were instructed to empty the bladder and drink 500cm3 of water 45-60 minutes before CT simulation and before every treatment fraction.

A conformal three-dimensional radiotherapy technique was planned to deliver to the primary tumor and the enlarged pelvic nodes a total dose of 39Gy in 13 sessions of 3Gy in 17 days.

Symptomatic response after the end of treatment has been measured for bleeding and pain and acute toxicity were reported according to CTCAEv4.0 scale.

Hypofractionated Palliative Radiotherapy in Patients With Advanced Non-operable Rectal Cancer

Palliative Hypofractionated Radiotherapy in Non-operable Rectal Cancer: A Retrospective Study

number of patients with bleeding ( worst, no change, better or without)

number of patients with pain ( worst, no change, better or without)

Gastrointestinal toxicity after the end of radiotherapy were reported according to CTCAE v4.0 scale

Genitourinary toxicity after the end of radiotherapy were reported according to CTCAE v4.0 scale.

Consorci Sanitari de Terrassa

Behaviors and Mental Disorders

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Quality of Life

Androgens

Prostate Immobilization Device

Anthony V. D'Amico, MD, PhD

During 3D-conformal external beam radiation therapy treatments for prostate cancer, the prostate gland moves. The purpose of this study is to determine whether the placement of a prostate immobilization device into the rectum during radiation treatments will decrease the risk of rectal bleeding that is sometimes seen as a late effect from radiation.

* MRI using an endorectal coil done prior to treatment for staging.
* Baseline Quality of Life (QOL) assessment will be completed prior to treatment.
* Total androgen suppression is initiated and will continue for at least 6 months.
* Prostate Immobilization Device (PID) placed during the planning session.
* PID will be placed daily for the first 15 3D external beam radiation treatments.
* QOL assessment and follow-up will take place every 6 months for 3 years.

Prostate Immobilization Device Used During Radiation Treatments to Decrease Rectal Bleeding

A Phase II Study of Late Rectal Toxicity Following 3-D Conformal External Beam Radiation Therapy Performed Using a Prostate Immobilization Device

Brigham and Women's Hospital

Dana-Farber Cancer Institute

Herbal and Botanical

Cola

Detection of neoplastic lesions in colon and rectum compared to colonoscopy

Pillcam® COLON Capsule

Niels Qvist, professor

The primary aim is to evaluate the efficiency of capsule endoscopy (CCE) in in the detection of neoplasms compared to conventional colonoscopy in persons participating in the Danish screening program for colorectal cancer with a positive fecal occult blood with the colonoscopy being the gold standard.

Participants will be recruited from the screening program, and are living on the main island of Funen. Persons with a positive FOBT who have been offered and have accepted a colonoscopy will be contacted by telephone and informed about the project by the project nurse.

The persons who accept participation and meet the inclusion criteria will be contacted by the study nurse for scheduling the capsule endoscopy according to the planned colonoscopy, which has to bee within 9-13 days after the result of the FOBT test.

The nurse will instruct the person to take the standard colon preparation 2 days before the colonoscopy, and stay from solid food until after the colonoscopy has been performed according to standard procedure. Thus the period with food-restrictions has to be extended by one day. A visit by the home services nurse the day before the colonoscopy will be arranged. The nurse will assist and supervise the intake of the video capsule and assists with the attachment of the monitor in a belt around the person's belly. Afterwards the questionnaire 1 (appendix 1) will be fulfilled by the patient with assistance from the nurse.

When the capsule has passed anus the monitoring equipment must be disarmed by the patient and stored according to the instructions. The patient will bring the recorder to the hospital the following day and deliver it to the study nurse, who will take care of data-transmission to the institute in Hamburg. After the colonoscopy and recovery period, the patient and the project nurse will fulfill the 2. questionnaire (appendix 2) and the colonoscopist will fulfill a standard report on the findings and treatment at colonoscopy (appendix 3), which will be added to the electronic database by the project secretary. The results form the colonoscopy will be the only information, that will be retrieved form the patients record.

Trained specialists in the Diagnostic Centre in Hamburg will perform the evaluation of the CCE and the data will be entered in a standard diagnostic report (appendix 4). The Diagnostic Centre will not have access to the results of the colonoscopy.

The CCE report must be available within 3 days, and the project responsible will evaluate the result according to the reported findings at colonoscopy. Any disagreement will be evaluated and discussed with the patient. In case of significant disagreement defined as a neoplasms of \> 9 mm found at CCE and not detected by colonoscopy the patient will be offered additional diagnostics in the form of repeated colonoscopy within 2 weeks or a CT colonography upon the decision by the patient.

Participants have to stay on a fluid diet for one day more than for the conventional investigation. This might be uncomfortable for some patients, but is without any health-related risk. Another side effect could be increased fecal content in the bowel at colonoscopy due to the extended time from bowel preparation to colonoscopy. In some cases this could result in an incomplete colonscopy, which then has to be repeated. The risk of this side effect is unknown but is considered to be below 5%.

The most significant complication to the CCE will be the risk of impaction of the capsule within the intestine, which may lead to surgery. The risk is minimized by the exclusion criteria and according to daily clinical experience the risk will be less than 0.5%, and will mainly occur in persons with an unknown intestinal pathology, which in the majority of the cases would necessitate surgical treatment anyway. There is no known risk with the monitoring equipment.

In the case of significant disagreement between the results form capsule endoscopy and the conventional colonoscopy the patient may risk further investigations, but on the other hand this could be an advantage for the patients in case of missed lesions at the colonoscopy. The risk of missing cancer or large polyps by colonoscopy is in the range of 1-2%.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Desmopressin (DDAVP) in Patients With Colorectal Cancer and Rectal Bleeding	NCT01623206	Colorectal Canc... Rectal Bleeding	Desmopressin	18 Years - 80 Years	Laboratorio Elea Phoenix S.A.
Treatment of Hemorrhagic Radiation Proctitis Using the Halo System	NCT01103492	Pelvic Neoplasm...	HALO90 Ablation...	18 Years -	University Hospitals Cleveland Medical Center
Informativeness to Digital Rectal Examination	NCT01727388	Colon Cancer Upper Rectum Ca... Diverticulitis Rectal Bleeding Hernia	lateral decubit... supine decubitu...	18 Years -	Centre Hospitalier Universitaire, Amiens
Treatment of Hemorrhagic Radiation Proctitis Using the Halo System	NCT01103492	Pelvic Neoplasm...	HALO90 Ablation...	18 Years -	University Hospitals Cleveland Medical Center
Hypofractionated Palliative Radiotherapy in Patients With Advanced Non-operable Rectal Cancer	NCT03853733	Rectal Cancer	rectal cancer r...	18 Years -	Consorci Sanitari de Terrassa
Hypofractionated Palliative Radiotherapy in Patients With Advanced Non-operable Rectal Cancer	NCT03853733	Rectal Cancer	rectal cancer r...	18 Years -	Consorci Sanitari de Terrassa
Prostate Immobilization Device Used During Radiation Treatments to Decrease Rectal Bleeding	NCT00114985	Prostate Cancer	Prostate Immobi...	31 Years - 80 Years	Dana-Farber Cancer Institute
Colonic Capsule Endoscopy (CCE) for Screening of Neoplasm's A Pilot Study	NCT02303756	Rectal Bleeding	Pillcam® COLON ...	50 Years -	Odense University Hospital

Spots Global Cancer Trial Database for rectal bleeding