Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Yunlu Feng, Doctor

Xiaoyan Wang, Doctor

The screened patients were randomly assigned 25G puncture needles and 22G puncture needles in a 1;1 ratio, based on the computer-generated random order, before receiving an ultrasound endoscope puncture. Each puncture needle puncture lesions 2 needles, the same type of puncture needle tissue samples taken in the same tissue pathology bottle, all tissues after the completion of the necessary cytological smears, are placed in the Formalin solution to send tissue pathology, pathologists do not know the order of distribution of 2 puncture needles to evaluate the tissue results, all pathology results are reported by the hospital pathology center, audit.

25G and 22G Puncture Needles

Multicenter, Randomized, Self-matched Design, Positive Control, Non-inferiority Clinical Study of 25G and 22G Puncture Needles in Solid or Submucosal Pancreatic Masses

A core tissue sample is defined as a sample with an histological structure that is fully used for tissue evaluation of target lesions.

The quality of tissue samples obtained by puncture is assessed by the pathologist, whether intact tissue structure is preserved, and the length of tissue strips

The quality of tissue samples obtained by punctures is evaluated by pathologists, technical success means that puncture 2 needles can obtain sufficient tissue samples for analysis to be evaluated by endoscopy.

Adverse events refer to adverse medical events that occur in the course of research, including punctured complications such as bleeding, abdominal pain, infection, pancreatitis, etc. throughout the study process.

Peking Union Medical College Hospital

Esophageal Neoplasms

Stomach Neoplasms

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Stomach Cancer

Michael H. Larsen, M.D.

Michael H Larsen, M.D.

Michael B. Mortensen, M.D., Phd

Endoscopic submucosal dissection (ESD) is a relatively new modality for the treatment of superficial gastrointestinal neoplasia and especially in the diagnosis and treatment of submucosal tumors. ESD has become a minimal invasive alternative to surgery but requires a high degree of endoscopic skills to be performed safely, it is time consuming, and less safe than endoscopic mucosa resection.

New endoscopic instruments have been developed to increase the efficacy and safety of ESD, and a combined endoscopic instrument (HybridKnife) has been developed and evaluated with promising results in animal studies. This HybridKnife allows high-pressure water-jet (submucosal) dissection, as well as cutting and coagulation and makes ESD possible without changing instrument.

The purpose of this study is to evaluate the feasibility and safety of using HybridKnife for ESD in humans.

Endoscopic Submucosal Dissection in Upper Gastrointestinal Canal With HybridKnife

Odense University Hospital

Michael Bau Mortensen

Study title	NCT ID	Conditions	Eligibility	Organization
25G and 22G Puncture Needles	NCT05101772	Submucosal Tumo... Pancreas Tumor	18 Years -	Peking Union Medical College Hospital
Endoscopic Submucosal Dissection in Upper Gastrointestinal Canal With HybridKnife	NCT01185483	Endoscopy, Dige... Esophageal Neop... Stomach Neoplas...	18 Years - 85 Years	Odense University Hospital
Endoscopic Submucosal Dissection in Upper Gastrointestinal Canal With HybridKnife	NCT01185483	Endoscopy, Dige... Esophageal Neop... Stomach Neoplas...	18 Years - 85 Years	Odense University Hospital
25G and 22G Puncture Needles	NCT05101772	Submucosal Tumo... Pancreas Tumor	18 Years -	Peking Union Medical College Hospital

Spots Global Cancer Trial Database for submucosal tumor