Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Adenoma

Stomach Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Stomach Cancer

Coagulants

All Drugs and Chemicals

Dermatologic Agents

Hemostatics

Menthol

Patients who require therapeutic upper gastrointestinal endoscopy, such as polypectomy, endoscopic hemostasis, percutaneous endoscopic gastrostomy (PEG), endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), will receive an intragastric spraying of NPO-11. The efficacy of NPO-11 as an anti-peristaltic agent for the endoscopic therapeutic procedures will be evaluated based on the proportion of patients with suppressed gastric peristalsis during the procedures. The degree of gastric peristalsis is assessed by an independent committee.

The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions (ADRs) observed between administration and seven days after administration.

Phase III Open-labeled Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy

No or mild gastric peristalsis is defined as when patients have no or suppressed gastric peristalsis during the therapeutic procedure (for 45 s). The degree of gastric peristalsis in the time periods is assessed by an independent committee.

Nihon Pharmaceutical Co., Ltd

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Pharmaceutical Solutions

Gastrointestinal Agents

Lactulose

Sodium sulfate

In the LOS group, patients were instructed to drink 200ml lactulose (Duphalac, Olst, the Netherlands; 200ml/bottle) diluted with clear water into 1L 4-6h before colonoscopy at a rate of 250ml every 30min.

Lactulose oral solution

patient in the PEG group were instructed to drink 2L of PEG (each liter containing 59g PEG 4000, 1.46g sodium chloride, 5.68g sodium sulfate, 0.74g potassium chloride, 1.68g sodium bicarbonate; WanHe Pharmaceutical Co, Ltd., China) 4-6h before colonoscopy at a rate of 250ml every 15min

Xiaofeng Zhang, MD

Adequate quality of bowel preparation(BP) is essential for colonoscopy. In recently, Kang suggested that for low-risk patients, single dose of 2L PEG is an effective regimen for bowel preparation.However, due to the poor palatability, there still more than 30% patients with 2L regimen experienced nausea or vomiting in our center.

Oral lactulose is a treatment for constipation. Several studies have compared the effectiveness between use PEG and lactulose for colonoscopy preparation in average-risk patients. However, the data in low-risk patients is vacant. The objective of current study was to compared the effectiveness of bowel preparation and patient tolerance using lactulose and 2L PEG regimen in low-risk patients.

Comparison of Oral Lactulose Versus Polyethylene Glycol for Bowel Preparation in Low-risk Patients

1L Oral Lactulose is an Effective Regimen for Bowel Preparation in Low-risk Patients

Boston bowel preparation score (BBPS)：cleanliness of each part of the colon: 0=unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared; 1=portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen because of staining, residual stool, and/or opaque liquid; 2=minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3=entire mucosa of colon segment seen well with no residual staining, small fragments of stool, or opaque liquid.

We will ask patients in the form of questionnaire whether they are willing to repeat the same bowel preparation method if they need colonoscopy examination again

Zhang Xiaofeng,MD

chief physician

Infections

Wounds and Injuries

Symptoms and General Pathology

Communicable Diseases

Head and Neck Neoplasms

Wound Infection

Anti-Infective Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

PEG-Gastropexy

Yogesh M Shastri, MD, DNB

Peristomal infections are the commonest complications of PEG despite prophylactic antibiotics which may result in emergence of resistant micro-organisms like Methicillin resistant Staphylococcus aureus (MRSA). Introducer PEG technique avoids the sojourn of PEG catheter through the oropharynx so chances of infectious complications are negligible. It was not popular because of associated risks and complications. However the new introducer PEG gastropexy has been recently proved to be safe. To determine the incidence of peristomal wound infections during the immediate 7 day post procedure follow up period after the new introducer PEG gastropexy

BACKGROUND:PEG can be performed by pull, push or introducer technique, pull method is the one most commonly used worldwide. PEG site infection is clearly the commonest procedure related complication of PEG placement and the routinely used pull technique has been shown to have quite high (4-30%), peristomal infectious complications. To curtail these infectious complications various gastroenterological societies have recommended giving intravenous prophylactic antibiotics 30 minutes prior to the procedure which has been shown to significantly reduce this complication. Despite this the incidence of peristomal infectious complications remains high post PEG. Another problem associated with the administration of prophylactic antibiotics is the emergence of resistant micro-organisms especially the Methicillin resistant Staphylococcus aureus (MRSA) at the PEG site. Introducer PEG is the technique of PEG placement which avoids the transit of PEG catheter through the oropharynx. Despite its introduction since 19 years back it has not become popular among endoscopists because of technical difficulties and complications associated with it. However the newer introducer PEG technique using endoscopic gastropexy has been shown to be quite safe and easy to perform in recent studies. We at our institute have been performing this procedure since January 2003 and on prospective follow up have found much lower incidence of peristomal infections with it. Recently Maetani et al have already demonstrated in a prospective randomised trial that the introducer type PEG results in fewer infectious complications as compared to conventional pull PEG. There is no study comparing introducer PEG technique with or without administration of prophylactic antibiotics. As in principal, the chances of infections are much lower in the introducer technique. We want to address this issue in a randomised double blind placebo controlled settings in those patients who will as it is unfit to undergo routine pull PEG because of upper gastrointestinal (UGI) malignant stenoses.

SUMMARY: Peristomal infections are the commonest complications of PEG despite prophylactic antibiotics which may result in emergence of resistant micro-organisms like Methicillin resistant Staphylococcus aureus (MRSA). Introducer PEG technique avoids the travel of PEG catheter through the oropharynx which is richly inhabitated with microorganisms so chances of infectious complications at the raw PEG wound are negligible. This technique was not popular because of associated risks and complications in the past which has shown it to result in complications like deflation of balloons, catheter dislodgement, leading to peritonitis etc. However the new introducer PEG gastropexy has been recently proved to be safe. At our institute about 200 PEG procedures are performed annually, out of these 10-12% have tight stenotic stricture in which pull PEG is not possible without dilatation of oropharyngeal tract. We plan to randomise these patients in to 2 groups with and without antibiotics (placebo). PEG will be done using the new introducer PEG, Freka® Pexact CH/FR 15 (Fresenius Kabi, Germany), in which the gastric wall is sutured non surgically to the anterior abdominal wall using 2 silk sutures. Peristomal wound would be assessed daily for 7 days using 2 types of point scores systems (given by Jain and by Gossner) by 2 members of nutrition support team independently. As these are the objective scoring systems, we intend to determine the grades of post procedure peristomal infections in these patients.

Role of Prophylactic Antibiotics in New Introducer PEG-Gastropexy

New Introducer PEG-Gastropexy Does Not Need Prophylactic Antibiotics: Prospective Randomised Double Blind Placebo Controlled Trial

Bethanien Krankenhaus gGmbH

Johann Wolfgang Goethe University Hospital

Polyps

Rectal Diseases

Antiemetics

Cardiotonic Agents

Herbal and Botanical

Erythromycin

Erythromycin Estolate

Erythromycin Ethylsuccinate

Erythromycin stearate

Metoclopramide

Bisacodyl

Sennosides

Dopamine

Dopamine Antagonists

Dopamine Agents

Neurotransmitter Agents

Enzyme Inhibitors

Laxatives

Cathartics

Cola

Senna

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of polyethylene glycol (PEG) on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-CONTROL

Senna tablets

SUPREP oral sulfate solution

SUPREP oral sulfate solution with Gastrografin

Douglas K Rex, Dr.

This study is designed to determine the optimal bowel preparation regimen for PillCam® COLON 2 Capsule Endoscopy System (CCE) procedures in average risk patients.

Patients will be randomized to receive one of two bowel preparation regimens prior to PillCam CCE.

This is a multicenter, prospective, consecutive, randomized study. Average-risk subjects undergoing CCE without optical colonoscopy will be consecutively enrolled and randomized 1:1 to receive one of two bowel preparation regimens prior to PillCam CCE.

Subjects will be enrolled at 5-10 clinical sites in the United States. Subjects who meet the eligibility criteria will be screened for study participation at a baseline visit and will be evaluated on the procedure day or until capsule excretion. A telephone follow-up will be conducted 5 to 9 days post-capsule ingestion to verify capsule excretion, assess patient well-being, and capture any adverse events.

Optimization of the Bowel Preparation Regimen for the PillCam® COLON 2 Capsule Endoscopy Procedure

COVGIC20482: A Multicenter, Consecutive, Randomized Study to Optimize the Bowel Preparation Regimen for the PillCam COLON 2 Capsule Endoscopy Procedure

The primary endpoint is the bowel cleansing level, as determined by a standardized 4-point grading scale, assessed in total and by segment (cecum, ascending, transverse, descending/sigmoid, and rectum).

Will be assessed from RAPID video in total and by segment

Colonic transit time of two different bowel preparation was assessed from RAPID video in total and by segment

Will be assesses by applicable case report form (CRF)

Medtronic - MITG

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-Control

Senna tablets

PEG

Metoclopramide

Erythromycin

SUPREP oral sulfate solution

Bisacodyl

Bowel Preparation Regimen -Control

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-Test

Senna tablets

PEG

Metoclopramide

Erythromycin

Bisacodyl

SUPREP oral sulfate solution with Gastrografin

Bowel Preparation Regimen-Test

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-CONTROL

Senna tablets

PEG

Metoclopramide

Erythromycin

SUPREP oral sulfate solution

Bisacodyl

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Liron Bar Yaakov

Overall Excellent cleansing

Cecum Excellent cleansing

Ascending Excellent cleansing

Transverse Excellent cleansing

Descending Excellent cleansing

Rectum Excellent cleansing

Overall Good cleansing

Cecum Good cleansing

Ascending Good cleansing

Transverse Good cleansing

Descending Good cleansing

Rectum Good cleansing

Overall Fair cleansing

Cecum Fair cleansing

Ascending Fair cleansing

Transverse Fair cleansing

Descending Fair cleansing

Rectum Fair cleansing

Overall Poor cleansing

Cecum Poor cleansing

Ascending Poor cleansing

Transverse Poor cleansing

Descending Poor cleansing

Rectum Poor cleansing

this was calculated on the per protocol analysis (PPAS) set excluding patients with one (or more) unseen segment in Cecum, Ascending and Transverse colon.

Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)

Overall (any size)

Cecum (any size)

Ascending (any size)

Transverse (any size)

Descending (any size)

rectum (any size)

Overall (polyps ≥6mm)

Cecum (polyps ≥6mm)

Ascending (polyps ≥6mm)

Transverse (polyps ≥6mm)

Descending (polyps ≥6mm)

Rectum (polyps ≥6mm)

Overall (polyps ≥10mm)

Cecum Overall (polyps ≥10mm)

Ascending Overall (polyps ≥10mm)

Transverse (polyps ≥10mm)

Descending (polyps ≥10mm)

Rectum (polyps ≥10mm)

This analysis is a subset of the PPAs excluding patients with one or more missing video data for Cecum, Ascending and transverse colon. Patients with at least one polyp detected on overall segments.

Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE

Bowel Preparation Regimen - Control

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure- Test

Senna tablets

PEG

Metoclopramide

Erythromycin

Bisacodyl

SUPREP oral sulfate solution with Gastrografin

The following patients were excluded from the analysis:2 withdrawn patients, 1 LTF (Lost to follow-up) patient, 2 pattients with failed prcedure, 16 patients with incomplete COLON exam.

Colonic Transit Time of Two Different Bowel Preparation Methods for PillCam CCE

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure- Control

Senna tablets

PEG

Metoclopramide

Erythromycin

SUPREP oral sulfate solution

Bisacodyl

Comparing of Completion Rate of Capsule of Two Different Bowel Preparation Methods for PillCam CCE

PPAS: Subjects withdrawn prior to the PillCam procedure (3) and subjects with one or more of the following protocol deviations (13) have been excluded: Evening PEG intake \<1h and \> 2.15h, Morning PEG intake \<1h and \>2:15 h, Capsule ingestion l\<45 min or \>75 min after PEG intake , Overall PEG intake volume is less than 3 liters

Excretion Rate of Capsule Within 12 Hours of Two Different Bowel Preparation Methods for PillCam CCE

Adverse Events Rate Between Two Different Bowel Preparation Methods for PillCam CCE

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of polyethylene glycol (PEG) on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-CONTROL

Senna tablets

PEG

Metoclopramide

Erythromycin

SUPREP oral sulfate solution

Bisacodyl

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase III Open-labeled Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy	NCT01411189	Gastric Cancer Colon Nos Polyp... Gastric Adenoma	Menthol	20 Years -	Nihon Pharmaceutical Co., Ltd
Comparison of Oral Lactulose Versus Polyethylene Glycol for Bowel Preparation in Low-risk Patients	NCT05648318	Colonic Neoplas...	Lactulose oral ... PEG	18 Years - 70 Years	First People's Hospital of Hangzhou
Role of Prophylactic Antibiotics in New Introducer PEG-Gastropexy	NCT00375414	Head and Neck N... Wound Infection	PEG-Gastropexy	16 Years - 88 Years	Johann Wolfgang Goethe University Hospital
Phase III Open-labeled Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy	NCT01411189	Gastric Cancer Colon Nos Polyp... Gastric Adenoma	Menthol	20 Years -	Nihon Pharmaceutical Co., Ltd
Optimization of the Bowel Preparation Regimen for the PillCam® COLON 2 Capsule Endoscopy Procedure	NCT02481219	Colorectal Canc...	PillCam® COLON ... Senna tablets PEG Metoclopramide Erythromycin SUPREP oral sul... Bisacodyl SUPREP oral sul...	50 Years - 75 Years	Medtronic - MITG
Role of Prophylactic Antibiotics in New Introducer PEG-Gastropexy	NCT00375414	Head and Neck N... Wound Infection	PEG-Gastropexy	16 Years - 88 Years	Johann Wolfgang Goethe University Hospital

Spots Global Cancer Trial Database for peg

Every month we try and update this database with for peg cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for peg

Every month we try and update this database with for peg cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for peg cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.