Digestive System Diseases

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Rare Diseases

Gastrointestinal Diseases

Gastroesophageal Reflux

Fistula

Gastroparesis

Esophageal Achalasia

Gastric Outlet Obstruction

Pyloric Stenosis

Constriction, Pathologic

Pathological Conditions, Anatomical

Stomach Diseases

Paralysis

Neurologic Manifestations

Idiopathic Achalasia

Cardiospasm

These procedures include: POEM (Peroral Endoscopic Myotomy) for Achalasia, G-POEM (Gastric Peroral Endoscopic Myotomy) for gastric outlet obstruction, Z-POEM (Peroral endoscopic myotomy for Zenker's Diverticulum), EMR (Endoscopic Mucosal Resection), ESD (Endoscopic submucosal dissection), STER (Submucosal tunneling endoscopic resection), NOTES (Natural Orifice Translumenal Endoscopic Surgery), TIF (Transoral Incisionless Fundoplication), Endoscopic Fistula Closure, Endoscopic Suturing, Capsule Endoscopy and EFTR (Endoscopic full-thickness resection).

Endoscopic Surgery

Michel Kahaleh, MD

Currently, there is limited multi-center data on endoscopic surgery outcomes in western populations.

Evaluation of these measurement would help the investigators compare them to conventional treatment modalities within current tertiary facilities; and consequently help the investigators identify appropriate treatment techniques and improve clinical management of patients at Rutgers RWJMS.

The purpose of this retrospective registry study is to assess long term data on efficacy, safety and clinical outcome of Endoscopic Surgery within the gastrointestinal tract.

Our tertiary-care institution performs clinically-indicated various Endoscopic Surgery procedures gastrointestinal indications in more than 800-1000 patients annually.

The study investigators would collect data on a large sample size of subjects undergoing various endoscopic resection procedures such as POEM (Peroral Endoscopic Myotomy), EMR (Endoscopic Mucosal Resection), ESD (Endoscopic submucosal dissection), STER (Submucosal tunneling endoscopic resection), NOTES (Natural Orifice Translumenal Endoscopic Surgery), TIF (Transoral Incisionless Fundoplication), Endoscopic Fistula Closure, Endoscopic Suturing, Capsule Endoscopy and EFTR (Endoscopic full-thickness resection). Clinical metrics will be collected including procedure times, length of follow-up, specific tumor characteristics, resection method, pathology results, procedural complications, additional therapy required, and disease-free survival time.

Various endoscopic surgical procedures are less invasive than traditional surgery, have fewer side effects and provide better efficacy. Moreover, they can be available to patients who are ineligible for surgery or who have refused more aggressive surgical intervention.

They improve quality of life and extend survival duration.

Endoscopic surgery procedures can be an appropriate approach in many gastrointestinal disorders including early neoplasms, challenging adenomas or sub-epithelial lesions that requires the resection of the superficial layers, mucosa and submucosa, or full thickness resection of the tract wall.

Currently, there is limited multi-center data on endoscopic surgery outcomes in western populations.

Evaluation of these measurement would help the investigators compare them to conventional treatment modalities within current tertiary facilities; and consequently help the investigators identify appropriate treatment techniques and improve clinical management of patients at Rutgers RWJMS.

The purpose of this retrospective registry study is to assess long term data on efficacy, safety and clinical outcome of Endoscopic Surgery within the gastrointestinal tract.

Endoscopic Surgery for Gastrointestinal Disorders: A Multicenter Registry Study

Data will not be shared with other researchers.

Type, frequency and intensity of adverse events

Chart Review of quality-of-life improvement and overall survival duration

Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University

Neoplasms

Pancreatic Pseudocyst

Cysts

Pancreatic Cyst

Pancreatic Diseases

Patients who undergo pancreatic pseudocystgastrostomy via a NOTES technique.

An operation to connect the pancreatic pseudocyst to the stomach so it can drain into the stomach and intestines

Pancreatic Pseudocystgastrostomy

John R Romanelli, MD

Natural Orifice Translumenal Endoscopic Surgery (NOTES) describes a new field of investigational surgery which uses the endoscope as the primary operative tool. The insertion sites for the endoscope include natural orifices such as the mouth, anus, vagina, or urethra. Multidisciplinary teams consist of surgeons and gastroenterologists who are collaborating to develop safe and effective surgical techniques via the natural orifice route in order to avoid surgical incisions. Pancreatic pseudocysts are cavities that form typically in the lesser sac following an episode of acute pancreatitis, that may be able to be drained by a variety of techniques, including endoscopically. Chronic pseudocysts often require surgical drainage into the stomach. The medical device company known as "Power Medical Interventions" has a computer-powered surgical stapler which rests on a flexible shaft. Following the insertion of the endoscope, the powered stapler will be passed alongside the endoscope to help the surgeon and gastroenterologist (working as a team) to see where to properly place the stapler. Once the stapler is in position, one jaw of the stapler will be placed into the pseudocyst, and the other jaw will be left in the stomach. The stapler will then be closed and fired, creating a permanent connection between the two hollow spaces and allow the contents of the pseudocyst to drain naturally out into the stomach and intestines. Utilizing this technique, a surgical incision is avoided.

Hypothesis: Patients who undergo the Natural Orifice Translumenal Endoscopic Surgery for treatment of their pancreatic pseudocyst will experience effective treatment with less discomfort and with quicker recovery than standard surgical techniques.

Introduction: Natural Orifice Translumenal Endoscopic Surgery (NOTES) describes a new field of investigational surgery which uses the endoscope as the primary operative tool. Multiple animal studies utilizing similar techniques are ongoing at several institutions, including Baystate Medical Center. These multidisciplinary teams consist of surgeons and gastroenterologists who are collaborating to develop safe and effective surgical techniques via the natural orifice route in order to avoid surgical incisions.

Pancreatic pseudocysts are cavities that form typically in the lesser sac following an episode of acute pancreatitis. These pseudocysts may become infected, and may have detrimental outcomes caused by their mass effect on the stomach and/or small intestine. Pseudocysts are able to be drained by a variety of techniques, including endoscopically. Chronic pseudocysts often require surgical drainage into the stomach or jejunum as they may contain solid material that does not drain. Typically, cystgastrostomies or cystenterotomies are performed utilizing an abdominal incision with subsequent suturing or stapling.

The medical device company known as "Power Medical Interventions" has a computer-powered surgical stapler which rests on a flexible shaft. There has been subsequent development of a linear version of this stapler which was designed for gastrointestinal anastomosis which will be utilized in this research project known as a "powered stapler".

An endoscope would be inserted in the mouth, and down into the stomach after the induction of general anesthesia. Following the insertion of the endoscope, the powered stapler will be passed alongside the endoscope to help the surgeon and gastroenterologist (working as a team) to see where to properly place the stapler. If a connection has been previously made between the stomach and pseudocyst, the stapler will be maneuvered into the proper position. If a connection has not yet been made, this will be done during the procedure with the aid of an endoscopic ultrasound probe passed through the mouth. Once the stapler is in position, one jaw of the stapler will be placed into the pseudocyst, and the other jaw will be left in the stomach. The stapler will then be closed and fired, creating a permanent connection between the two hollow spaces and allow the contents of the pseudocyst to drain naturally out into the stomach and intestines. The stapler and the endoscope are then removed and the anesthesia is allowed to wear off. Utilizing this technique, a surgical incision is avoided.

Primary Objective: The primary objective of this study is to demonstrate that the Natural Orifice Translumenal Endoscopic Surgery (NOTES) technique is as effective as standard surgical technique for the permanent drainage of pancreatic pseudocysts.

Secondary Objective: The secondary objective of this research project is to demonstrate a decreased degree of pain experienced by patients undergoing the Natural Orifice Translumenal Endoscopic Surgery versus traditional methods.

Hypothesis: Patients who undergo the Natural Orifice Translumenal Endoscopic Surgery for treatment of their pancreatic pseudocyst will experience effective treatment with less discomfort and with quicker recovery than standard surgical techniques.

Background: The NOTES team (surgeon and gastroenterologist) at Baystate has extensive experience with animal work in developing novel techniques with commercially available products. While we have not ever performed a cystgastrostomy on an animal, there is no known animal model to simulate this pathologic condition. We have, however, operated the flexible gastrointestinal anastomotic stapler translumenally in an animal model in order to prepare for this procedure. The surgeon on the team has performed human stapled cystgastrostomies before, via both open and laparoscopic approaches. A pilot case has recently been done performed and the patient continues to do well.

Study Design: There will be a total of 10 patients undergoing this experimental surgical procedure once meeting all entry criteria and subsequent to obtaining informed consent. Follow-up endoscopic examination will be conducted approximately 6 weeks following the procedure to determine the success of the drainage of the pseudocyst. Longer term follow-up will be determined by the patient's overall condition. These 10 patients will be compared to a retrospective review of 10 patients to compare pseudocyst size, degree of pain and hospital length of stay. The degree of pain will be assessed using the Wong-Baker Pain Scale. The retrospective series will be a matched cohort based on size of the pseudocyst and age and comorbidities of the patient.

Safety Monitoring: Due to the novelty of the procedure, safety information will be monitored on a continuous basis. Should there be any untoward results, the study may be terminated prematurely, or temporarily suspended while we assess the events. In the event of any serious adverse event or outcome, the IRB will be notified immediately.

Risks and Benefits: The anticipated risks associated with this type of surgery include:

Bleeding, infection, need for open surgery, pancreatic leak, gastric leak, inadequate drainage of the pseudocyst. A risk specific to the NOTES approach includes trauma to oropharynx resulting in bleeding or infection.

The anticipated benefits include a decrease in the amount of pain experienced with the drainage of the pancreatic pseudocyst, as well as an anticipated decreased length of hospital stay.

Statistics: A comparison of the means will be performed using both the numerical values from the Pain Scale, the largest diameter of the pseudocyst, and the hospital length of stay.

Data Storage: The data collected will be kept in a locked filing cabinet in the primary investigator's office. Only the PI will have access to this file.

Enrollment Inclusion Criteria:

1. Adult (over 18 years old) patients who are able to provide informed consent for this surgical procedure
2. Patients scheduled to undergo non-emergent surgical treatment removal of pancreatic pseudocyst

Enrollment Exclusion Criteria:

1. Inability to provide informed consent
2. Patients who, in the opinion of the investigator, would not be appropriate for enrollment into this experimental research project
3. Patients who are deemed to be unstable from a medical standpoint to undergo pancreatic surgery
4. Pregnancy

It is anticipated that there will be more similar type of "natural orifice" type surgeries in the future for a variety of procedures and a multitude of reasons (no incision, less pain, and less time in the hospital). This surgery is the first of its kind for the drainage of pancreatic pseudocysts.

Natural Orifice Translumenal Endoscopic Surgery (NOTES) Cystgastrostomy for the Treatment of Pancreatic Pseudocysts

Number of patients who died as a result of the surgery: Death (mortality).

Please note that pain was previously listed as an outcome measure, but this was edited out of this submission and was not tracked as an outcome measure.

Baystate Medical Center

Medical Director, Weight Loss Surgery Program

Patients who undergo pancreatic pseudocystgastrostomy via a NOTES technique. All of them are candidates for open or laparoscopic pancreatic pseudocystgastrostomy, but have chosen a less invasive result. Also, all of them have to have imaging criteria which suggest that the stomach and pseudocyst are in close contact, and that the cyst is proximal enough in the stomach to be reachable with an endoscope and/or endoscopic stapler.

NOTES Pancreatic Pseudocystgastrostomy Patients

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Early termination due to the company that made the device going out of business; the company that acquired it chose not to market the device. Given the lack of clinical support, we chose to terminate the study.

Dr. John R. Romanelli

Pancreatic Pseudocystgastrostomy Patients having NOTES procedure

Patients who had the diagnosis, qualified anatomically, and were interested in the research study (and who met inclusion criteria but not exclusion criteria) were enrolled.

Mortality

Overall Study

Cicatrix

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Intestinal Diseases

Rectal Diseases

no-scar transanal total mesorectal excision(TME) of rectal cancer

no-scar transanal total mesorectal excision(TME)

Jianping Wang, MD

During the past three years, a revolutionized radical surgical approach for rectal cancer ("down to up TME " approach or "transanal TME (TaTME)"approach, which is opposite to the conventional approach) has emerged and it is a concept that combines natural orifice transluminal endoscopic surgery(NOTES) and total mesorectal excision(TME) with curative intent. The feasibility, safety and reproducibility of it were first demonstrated in swine survival experiments and subsequently in human cadaver series, and then it was successfully applied to human patients in few centers around the world, most of which were performed with assistance of laparoscopy, namely hybrid transanal TME. In addition, pure-NOTES without conventional laparoscopic assistance (no scar) has also been demonstrated, though the cases were more limited. In the initial stage, our group has successfully performed this no-scar transanal TME in a series of human cadavers with satisfactory outcome. Hence the investigators conduct this study, looking to see if this pure transanal NOTES investigational procedure is a safe and effective approach to radically remove rectal cancer of the mid and lower rectum and meanwhile, if it can reduce pain, gain faster recovery and better function and life quality when gaining the best cosmetic effect.

Transanal total mesorectal excision (TaTME) is a novel development in the field of colorectal surgery which combines the mini-invasive concept of natural orifice transluminal endoscopic surgery(NOTES), the technique of single-port laparoscopic surgery and the principle of total mesorectal excision with curative intent for treating rectal cancer. Based on the platform of either transanal endoscopic microsurgery(TEM) or transanal minimally invasive surgery (TAMIS), it is an innovative way of retrograde TME dissection from bottom to up with or without laparoscopic assistance. It is supposed to facilitate distal rectal mobilization, thus achieving precise and sufficient distal margin and to reduced need for multiple stapler firings in transecting the rectum, consequently decreasing anastomotic leakage rates which is especially important for obese male patients with a narrow pelvis where exposure to the distal rectum from the abdominal approach can prove difficult. It could also protect neurovascular bundle with better visualization and exposure and has the advantage of better function and avoiding sacrificing sphincter. After a series of preclinical trail of animal and cadaver, it has been successfully applied to humans and successional reports have proved its feasibility and safety. However, the majority of published series is hybrid NOTES, which need the assistance of conventional laparoscopic surgery from above to bottom and abdominal incision, scar, pain and incision related complications such as wound infection, abscess, hernia and implanted incisional tumors cannot be necessary avoided. It is also worried that the cost will increased since two groups of surgical equipment are needed(the abdominal and perineal) and more surgical staff are required if the two team operate at the same time(two-team approach). Up to date, as far as we have known, the pure transanal TME NOTES without any laparoscopic assistance has also been successfully performed in human patients though the cases are rare. The investigators of our center have also successfully performed pure-NOTES rectal resection in human cadavers in the past few months, and are confident to move this forward to conduct this pilot study to evaluate the feasibility and safety of this surgery in rectal cancer patients.

The Feasibility and Safety of No-scar Transanal Total Mesorectal Excision for Rectal Cancer

A Pilot Study of the Feasibility and Safety of No-scar Transanal Total Mesorectal Excision for Rectal Cancer Without Conventional Laparoscopic Assistance

To evaluate the feasibility and safety by operative time, estimated blood loss, intraoperative complications, convert to Hybrid NOTES or open surgery, pathological outcome including Total Mesorectal Excision (TME) quality, the lymph nodes harvested, and specimen length, circumferential margin, etc. and postoperative complications graded according to Clavien-Dindo, reoperation rate, 30-day mortality, 30-day readmission

To evaluate bladder function, anal function, sexual function and life quality by incontinence score, EORTC QLQ C30 and EORTC QLQ CR38, etc

To evaluate the postoperative outcome by length of hospital stay after operation, the time of first flatus, the time of recover to flow diet, postoperative pain by VAS, analgesic use ,etc

3-year disease free survival (DFS), 3-year local recurrence rate, 3-year distal metastasis rate, 3-year overall survival (cancer related or non-cancer related)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Endoscopic Surgery for Gastrointestinal Disorders: A Multicenter Registry Study	NCT05041608	Achalasia Gastric Outlet ... Gastroparesis GERD Reflux Fistula Benign Neoplasm	Endoscopic Surg...	-	Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
Natural Orifice Translumenal Endoscopic Surgery (NOTES) Cystgastrostomy for the Treatment of Pancreatic Pseudocysts	NCT00541593	Pancreatic Pseu...	Pancreatic Pseu...	18 Years - 90 Years	Baystate Medical Center
The Feasibility and Safety of No-scar Transanal Total Mesorectal Excision for Rectal Cancer	NCT02236884	Rectal Cancer Surgery	no-scar transan...	18 Years - 70 Years	Sun Yat-sen University

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Spots Global Cancer Trial Database for notes

Every month we try and update this database with for notes 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 notes 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.