Neoplasms

All Conditions

Digestive System Diseases

Adenoma

Duodenal Diseases

Intestinal Diseases

Gastrointestinal Diseases

Patients who consent to participate in this study will have a small sample of their adenoma and normal tissue sent for molecular testing.

A small sample of the duodenal adenoma will be obtained for molecular testing. The remaining adenoma will be sent for regular histological testing.

Tissue Sampling

Michael Bourke, MBBS, FRACP

The purpose is to investigate whether polyps that look different at endoscopy, have formed via different mutations and have different risks of turning into cancer.

Laterally spreading tumours (LSTs), are polyps that have a lateral extension along the duodenal wall with minimal vertical growth. It has become evident over the last few years that rather than being a single entity requiring an accumulation of mutations, Duodenal and ampullary cancer is in fact a heterogenous disease forming via multiple distinct genetic pathways. It is therefore hypothesised that different polyp types have different genetic abnormalities, and potentially form via distinct genetic pathways, although this theory has not been widely examined.

This knowledge would be important in furthering our understanding of the development of cancer. There is accumulating evidence that genetic abnormalities may be a better predictor of cancer behaviour than histological grade. Additionally, guidelines for endoscopy surveillance are currently a one size fits all approach that do not reflect the genetic heterogeneity of the disease and the knowledge that only 5% of polyps progress to cancer. Genetic studies may assess future cancer risk to a person in polyps once removed and plan surveillance endoscopy frequency.

Adenoma tissue sample and control "regular" tissue sample

Endoscopic Characteristics of Duodenal and Ampullary Lesions

A Correlation of the Endoscopic Characteristics of Duodenal and Ampullary Laterally Spreading Tumours With Their Somatic or Germline Mutations.

The aim of this project is to look for statistically significant differences in molecular abnormalities from the three known genetic pathways, between the two different morphological types, granular and non-granular, to potentially demonstrate that these different polyps form via different genetic pathways.

Professor Michael Bourke

Director of Gastrointestinal Endoscopy

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

In the Cancer Hospital, postoperative chemotherapy regimens and doses were planned by oncologists, with adjustments made based on drug toxicities or tumor responses.

Adjuvant chemotherapy

Zheng Li, M.D.

Ampullary cancer, a rare malignancy, lacks standardized guidelines for effective multimodal treatment following curative resection. The opinions on whether postoperative chemotherapy can improve the long-term survival of ampullary adenocarcinoma (AA) are discordant. This aspect remains poorly studied, with comparably scant research conducted on it.

log odds of positive lymph nodes (LODDS), a quantitative variable, can continuously and accurately reflect the burden of nodal involvement, which suggested a potential ability to identify AA patients benefiting from postoperative adjuvant chemotherapy (ACT). Therefore, Mainly focused issues of ACT addressed in the study are as follows: 1) the role of ACT in improving long-term survival for patients with AA after curative resection. 2) the role of LODDS in identifying postoperative AA patients benefiting from ACT. 3) compared with T and N classifications reported previously, the advantage of LODDS in identifying ACT-benefited patients.

In this cohort study, a large scale of sample size was conducted by drawing on the collective experience of the National Cancer Center of China. The patients treated with radiotherapy were excluded to concentrate on the effect of ACT.

Quantitative Nodal Burden as a Determinant Identifying Ampullary Adenocarcinoma Patients Benefiting From Adjuvant Chemotherapy

Quantitative Nodal Burden as a Determinant Identifying Ampullary Adenocarcinoma Patients Benefiting From Adjuvant Chemotherapy: A Retrospective Cohort Study

The association between ACT and Overall Survival (OS) of patients

The association between ACT and Cancer-specific Survival (CSS) of patients

The association between ACT and Recurrence-free Survival (RFS) of patients

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Deputy director

Diseases and Abnormalities at or Before Birth

Symptoms and General Pathology

Rare Diseases

Adenomatous Polyposis Coli

Polyps

Adenomatous Polyps

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Syndrome

Neoplastic Syndromes, Hereditary

Colonic 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

Recurrence

Disease Attributes

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 Characteristics of Duodenal and Ampullary Lesions	NCT01556399	Duodenal Diseas...	Tissue Sampling	18 Years - 85 Years	Western Sydney Local Health District
Quantitative Nodal Burden as a Determinant Identifying Ampullary Adenocarcinoma Patients Benefiting From Adjuvant Chemotherapy	NCT06435767	Ampullary Adeno... Chemotherapy Ef...	Adjuvant chemot...	18 Years - 85 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Quantitative Nodal Burden as a Determinant Identifying Ampullary Adenocarcinoma Patients Benefiting From Adjuvant Chemotherapy	NCT06435767	Ampullary Adeno... Chemotherapy Ef...	Adjuvant chemot...	18 Years - 85 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Endoscopic Papillectomy for Ampullary Adenomas	NCT03494543	Ampullary Adeno... Familial Adenom...	Endoscopic Papi...	18 Years -	Arcispedale Santa Maria Nuova-IRCCS
Endoscopic Characteristics of Duodenal and Ampullary Lesions	NCT01556399	Duodenal Diseas...	Tissue Sampling	18 Years - 85 Years	Western Sydney Local Health District
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
Quantitative Nodal Burden as a Determinant Identifying Ampullary Adenocarcinoma Patients Benefiting From Adjuvant Chemotherapy	NCT06435767	Ampullary Adeno... Chemotherapy Ef...	Adjuvant chemot...	18 Years - 85 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 ampullary adenoma