Symptoms and General Pathology

All Conditions

Neoplasms

Recurrence

Adenoma

Disease Attributes

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Patients who are eligible will undergo thermal ablation of the resection margins.

Thermal ablation of resection margins by STSC and biliary orifice by cystotome.

Jeska A Fritzsche, MD

Jeska Fritzsche, MD

Rogier P Voermans, MD PhD

Recurrence after endoscopic papillectomy is described in up to 33% of the cases (range 12-33%). This leads to re-interventions, a cumulative risk of adverse events, and the need for long-term follow-up. Recurrences most likely originate from either the biliary orifice or lateral resection margins. Ablative methods such as radiofrequency ablation (RFA) and thermal ablation by cystotome inside the bile duct have been described to treat intraductal extension of which the use of a cystotome seems to have a more favorable safety profile. However, no studies focusing on the preventive use of these ablative methods in patient with papillary adenomas have been performed. It is hypothesized that the curative resection rate can be increased and recurrence prevented by using a combination of snare tip soft coagulation (STSC) of the resection margins and thermal ablation by cystotome of the biliary orifice in patients with and without the suggestion of intraductal extension.

Therefore, aim of this study is to assess the safety and feasibility of endoscopic papillectomy combined with thermal ablation of the biliary orifice by cystotome and STSC of the lateral resection margins.

Endoscopic Resection of Papillary Adenomas; a Novel Treatment Algorithm to Prevent Recurrence - a Pilot-study (ERASE-pilot)

i.e. pancreatitis, bleeding, cholangitis, perforation, and papillary stenosis.

Defined as absence of adenomatous residual tissue or recurrence observed in follow-up biopsy sampling.

Intraductal growth or invasive growth encountered by EUS and not other imaging

Succesfull treatment of post procedural bleeding e.g. no need for re-intervention or transfusion.

i.e. rate of adverse events such as pancreatitis, bleeding, cholangitis, perforation, and papillary stenosis.

Amsterdam UMC, location VUmc

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

R.P. Voermans MD PhD

Digestive System Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Adenomatous Polyposis Coli

Polyps

Adenomatous Polyps

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Syndrome

Neoplastic Syndromes, Hereditary

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Intestinal Polyposis

Genetic Diseases, Inborn

Familial Adenomatous Polyposis

MYH-associated Polyposis

Endoscopic resection of ampullary of Vater neoplasms

Endoscopic Papillectomy

Romano Sassatelli, MD

In this single-center experience we retrospectively evaluated principal clinical outcomes of endoscopic papillectomy in all patients referred to our unit. The same evaluation was then performed dividing sproradic ampullary adenoma from familial adenomatous polyposis associated adenomas, and resulting outcomes were compared.

INTRODUCTION Ampullary adenomas are rare tumors of digestive tract with a prevalence of 0.04% to 0.12%, but represent a large part of small intestinal neoplasms. They can origin from the duodenal epithelium or from the pancretobiliary one; the latter seems to have a worse prognosis in terms of nodal metastasis and local invasion with lower long term survival. In these kinds of lesion the adenoma-to-carcinoma sequence has been demonstrated, as already described in the colon.

Symptoms are variable and often are due to the growth of the lesion that can cause pancreatico-biliary obstruction, leading to jaundice and pancreatitis, gastric outlet obstruction, leading to sub-occlusive syndrome or nonspecific abdominal pain, and, rarely, bleeding. Commonly ampullary adenomas are asymptomatic and are discovered during esophagogastroduodenoscopy performed for several symptoms, such as dyspepsia and reflux syndrome, or during endoscopic screening in patients with familial adenomatous polyposis (FAP).

FAP is an autosomal dominant disease caused by mutation in the adenomatous polyposis coli (APC) genes. FAP patients develop colonic polyps in over 90% by age 35 years, while the duodenum is the second most common site of polyp formation. Duodenal/ampullary cancer is the second cause of cancer death in FAP and the risk of development it is 100- to 300-fold higher than the general population and is measured with the Spigelman score that ranges between stage I and IV on the basis of duodenal polyp number, size, histology and grade of dysplasia.

Considering the malignant potential of these lesions, above all in sporadic ampullary adenomas (SAA), complete excision is indicated. Otherwise, in patients with FAP the risk of adenoma to adenocarcinoma transformation seems to be lower and the need of resection is controversial. In the other hand management with annual or biennial surveillance, because of the documented stability of the situation, is suggested only in FAP patients when just minimal irregularity of the papilla is found and low-grade dysplasia was detected.

In the past years pancreatoduodenectomy or transduodenal resection, on the basis of the local invasion and of the local expertise, were the standard treatment, but these approach were burdened by high mortality and morbidity rates. In the last years case reports, retrospective and prospective series have demonstrated the feasibility and safety of the endoscopic resection for benign ampullary adenoma and for early stage ampullary carcinoma with not only diagnostic but also curative intent. Success rate of the endoscopic papillectomy (EP) ranges from 46 to 92% and recurrence rate from 0 to 33% and, recently, the same efficacy with low morbidity respect of surgery have been reported.

In this single-center experience we retrospectively evaluated principal clinical outcomes of EP in all patients referred to our unit. Subsequently the same evaluation was performed dividing SAA from FAP associated adenomas, and resulting outcomes were compared.

METHODS This study is a retrospective analysis of a prospectively collected database. All consecutive patients who underwent EP because of ampullary tumor at Arcispedale Santa Maria Nuova (Reggio Emilia, Italy) between January 2001 and December 2015 were considered. Patients with diagnosis of ampullary adenoma on the endoscopic resection specimen and with at least 24 months of follow-up were included in the analysis. Therefore, patients that underwent EP but without a diagnosis of adenoma or adenocarcinoma in the specimen were excluded from the study.

For all patients preprocedural, procedural and postprocedural data were collected. Preprocedural data were: age, gender, size of the ampullary adenoma, clinical presentation, histology of preprocedural biopsy, endoscopic ultrasound evaluation, and finally, only among patients with FAP, the Spigelman score was calculated. Procedural data were: pancreatic stent placement, biliary stent placement, intraductal invasion. Postprocedural data were: histology of the endoscopic resection specimen and histological subtype, 'en bloc' resection, complete resection, number of procedure to achieve a complete resection, adverse events, need for surgery, recurrence, histology of recurrence, management of recurrence, follow-up and survival.

All patients provided written informed consent to EP. This retrospective study was approved by our Institutional Reviewer Board and, thereafter, by the Ethics Committee.

OUTCOMES The primary outcome of the study was the technical success of EP, considered as achieved when all the following criteria were met: a) complete removal, even in multiple sessions b) absence of residues at histology (histology \<= pT1) at the first follow-up; c) recurrence successful treated by endoscopy (not surgery). Technical failure of EP was considered when at least one of the following criteria was met: a) histology\> pT1; b) residual adenomatous tissue not suitable of endoscopic resection; c) recurrence treated by surgery. Secondary outcomes were the number of procedures to achieve technical success, the incidence of adverse events, the incidence of recurrence, the concordance of histology pre- and post EP and the evaluation of factors related with technical success.

Finally outcomes of patients with SAA and patients with FAP were compared.

Endoscopic Papillectomy for Ampullary Adenomas

Endoscopic Papillectomy for Ampullary Adenomas: an Italian Single Centre Experience

The primary outcome of the study was the technical success of endoscopic papillectomy, considered as achieved when all the following criteria were met: a) complete removal, even in multiple sessions b) absence of residues at histology (histology \<= pT1) at the first follow-up; c) recurrence successful treated by endoscopy (not surgery). Technical failure of EP was considered when at least one of the following criteria was met: a) histology\> pT1; b) residual adenomatous tissue not suitable of endoscopic resection; c) recurrence treated by surgery

number of procedures to achieve technical success

concordance of histology pre- and post endoscopi papillectomy

Arcispedale Santa Maria Nuova-IRCCS

Principal Investigator

Endoscopic Papillectomy Combined with Endobiliary Radiofrequency Ablation

A snare devicewas inserted via the working channel, and the endoscopist adjusted the snare to securely grasp the lesion, which was then excised by using standard electrocautery.

The RFA catheter was then placed under fluoroscopic guidance across the distal common bile duct. An ERBE VIO200D generator (ERBE Elktromedizin, Tubingen, Germany) was connected for RFA at 10 W for 90 seconds.

Endobiliary Radiofrequency Ablation

Jianfeng Yang, Dr.

Endoscopic papillectomy is the preferred approach for management of ampullary adenomas. Endobiliary radiofrequency ablation (RFA) is an ablative therapy that has been used to treat malignant biliary strictures. The aim of this study was to evaluate the safety and efficacy of endoscopic papillectomy combined with endobiliary RFA for ampullary neoplasms with intraductal biliary extension.

Ampullary neoplasms remain rare, with a reported prevalence of 0.04% to 0.12% in autopsy studies. , endoscopic papillectomy is now recognized as a safe and reliable alternative to surgery for ampullary adenomas and is associated with high success rates (72%-95%), low morbidity (10%-30%), and minimal mortality (0.2%-1%). Typically, however, intrabiliary extension of the adenoma has been regarded as a contraindication for endoscopic papillectomy. Surgical referral is therefore recommended with intraductal extension, particularly when the length of extension exceeds 1 cm. Radiofrequency ablation offers a potentially safe and effective treatment for malignant biliary strictures. The use of RFA as a primary treatment for intraductal dysplasia after endoscopic papillectomy has been shown in few small case series to be feasible with the primary limitation of short follow-up periods. The primary aim of this study was to describe our experience with RFA in patients with ampullary neoplasia and associated intraductal extension who were not surgical candidates.

EP Combined With RFA for Ampullary Neoplasms With Intraductal Biliary Extension

The Efficacy and Safety of Endoscopic Papillectomy Combined With Endobiliary Radiofrequency Ablation for Ampullary Neoplasms With Intraductal Biliary Extension

Recurrence was defined as discovery of neoplasia after a negative surveillance endoscopy and biopsy

Complete resection of ampullary adenomas was confirmed when no residual tissue was found on ampullary and intraductal biopsies at the 3-month follow-up ERCP.

Endoscopic success was defined as complete ablation of the lesion without residual neoplasia or recurrence at the 6-month follow-up endoscopy.

adverse events such as bleeding, acute pancreatitis after procedure

First People's Hospital of Hangzhou

Professor

All Drugs and Chemicals

Proton Pump Inhibitors

Since this is a single arm cohort study the outcomes will be descriptive

patients undergoing endoscopic papillectomy will be included and treated according to the study algorithm.

* A papillary adenoma (abnormal tissue growth/ tumour at junction of bile duct \& intestines) will be removed completely by cutting \& removing abnormal tissue growth using a flexible tube containing a camera through the mouth.
* After the procedure you will be admitted in the hospital for at least 24 hours for observation,
* You will be asked to use medications which decrease acid production (PPIs- proton pump inhibitors) in stomach for 2 weeks to decrease the risk of bleeding.

Endoscopic papillectomy

Sonam Mathur, MD

Recurrence after endoscopic papillectomy is described in up to 33% of the cases (range 12-33%). This leads to re-interventions, a cumulative risk of adverse events, and the need for long-term follow-up. Recurrences most likely originate from either the biliary orifice or lateral resection margins. Ablative methods such as radiofrequency ablation (RFA) and thermal ablation by cystotome inside the bile duct have been described to treat intraductal extension of which the use of a cystotome seems to have a more favorable safety profile. However, no studies focusing on the preventive use of these ablative methods in patient with papillary adenomas have been performed.

Recurrence after endoscopic papillectomy is described in up to 33% of the cases (range 12-33%). This leads to re-interventions, a cumulative risk of adverse events, and the need for long-term follow-up. Recurrences most likely originate from either the biliary orifice or lateral resection margins. Ablative methods such as radiofrequency ablation (RFA) and thermal ablation by cystotome inside the bile duct have been described to treat intraductal extension of which the use of a cystotome seems to have a more favorable safety profile. However, no studies focusing on the preventive use of these ablative methods in patient with papillary adenomas have been performed. It is hypothesized that the curative resection rate can be increased and recurrence prevented by using a combination of snare tip soft coagulation (STSC) of the resection margins and thermal ablation by cystotome of the biliary orifice in patients with and without the suggestion of intraductal extension

Endoscopic Resection of Papillary Adenomas; a Novel Treatment Algorithm to Prevent Recurrence - a Pilot-study

rate of adverse events such as pancreatitis, bleeding, cholangitis, perforation, and papillary stenosis (at 9 months follow-up).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Endoscopic Resection of Papillary Adenomas; a Novel Treatment Algorithm to Prevent Recurrence - a Pilot-study (ERASE-pilot)	NCT05339607	Papillary Adeno...	Thermal ablatio...	18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Endoscopic Papillectomy for Ampullary Adenomas	NCT03494543	Ampullary Adeno... Familial Adenom...	Endoscopic Papi...	18 Years -	Arcispedale Santa Maria Nuova-IRCCS
EP Combined With RFA for Ampullary Neoplasms With Intraductal Biliary Extension	NCT05028465	Ampullary Adeno...	Endoscopic Papi... Endobiliary Rad...	18 Years - 80 Years	First People's Hospital of Hangzhou
Endoscopic Resection of Papillary Adenomas; a Novel Treatment Algorithm to Prevent Recurrence - a Pilot-study	NCT06216730	Ampullary Adeno...	Endoscopic papi...	18 Years - 80 Years	Asian Institute of Gastroenterology, India
Endoscopic Papillectomy for Ampullary Adenomas	NCT03494543	Ampullary Adeno... Familial Adenom...	Endoscopic Papi...	18 Years -	Arcispedale Santa Maria Nuova-IRCCS

Spots Global Cancer Trial Database for endoscopic papillectomy