Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Rare Diseases

Cholangiocarcinoma

Calculi

Constriction, Pathologic

Gallstones

Cholelithiasis

Cholecystolithiasis

Choledocholithiasis

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pathological Conditions, Anatomical

Bile Duct Diseases

Common Bile Duct Diseases

Biliary Tract Diseases

Gastrointestinal Diseases

Gallbladder Diseases

Bile Duct Cancer

Per standard treatment protocol for percutaneous cholangiopancreatoscopy, access will be gained into the biliary system using the biliary tube or into the gallbladder using the cholecystostomy tube. After access has been secured, through a peel-away sheath a Spy Glass Discover Digital Catheter will be introduced. Next, either, the stones will then be removed from the biliary system or gallbladder using a combination of baskets, and lithotripsy equipment as required, or in case of biliary strictures, a clamshell biopsy will be taken from the stricture site as identified on endoscopic visualization and cross-sectional imaging. Further intervention maybe performed for the stricture based on operator preference. After the complete stone removal/ stricture management the cholecystostomy/ biliary tube will be removed after the patient passes a clinical capping trial.

Percutaneous cholangiopancreatoscopy

Harjit Singh, MD

Hannatu Bwayili, BS

Tushar Garg, MD

The Percutaneous Cholangiopancreatoscopy (PCPS) registry is an observational, multicentric, prospective, and retrospective registry of patients undergoing the percutaneous cholangiopancreatoscopy procedure at sites across the United States. In the retrospective component of the study, clinical and procedural data regarding patients who have undergone clinical indicated percutaneous cholangiopancreatoscopy procedure in the past will be collected from all the registry sites and stored in a secure database. The prospective component of the registry will run for three years at each site where patients undergoing the clinically indicated percutaneous cholangiopancreatoscopy procedure will be enrolled in the study, and the patients' data will be collected whenever the patients present to interventional radiology (IR) for a procedure or clinic visit.

Percutaneous Cholangiopancreatoscopy Registry

The Percutaneous Cholangiopancreatoscopy Registry

Tube free survival will be calculated by estimating the number of patients who can undergo removal of the biliary/ cholecystostomy tube after the PCPS procedure until their last IR clinical follow-up or death.

Technical success is defined as successful access with cholangioscope and visualization of the stones or a lesion to be biopsied.

Procedural success in patients with calculi, is defined as either a) visualization of stones with at least partial stone removal, or b) visualization of biliary system demonstrating no need for further investigation; in patients with biliary stricture, defined as a) obtaining tissue for biopsy or b) successfully visualize and complete or partial treatment of the stricture.

Clinical success is defined as improvement in clinical symptoms (e.g., abdominal pain, fever, jaundice, nausea and vomiting), laboratory values and/or imaging findings.

Complication rate will be calculated by recording the adverse events that occur during the procedure in accordance with the Society of Interventional Radiology Classification System.

Complication rate will be calculated by recording the adverse events that occur after the procedure in accordance with the Society of Interventional Radiology Classification System.

Johns Hopkins University

Neuroendocrine Tumors

Carcinoid Tumor

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

Herbal and Botanical

All Drugs and Chemicals

Cola

Patients with midgut neuroendocrine tumor who will undergo only primary tumor surgery.

Patients with midgut neuroendocrine tumor that will undergo through primary tumor surgery combined with prophylactic cholecystectomy.

Primary tumor surgery

Large bowel resection combined and cholecystectomy.

Primary tumor surgery (bowel resection) combined with prophylactic cholecystectomy

Inés Ginot

Sandra Vela

Joan Altet

José Luís Sánchez

Luís Miguel Jiménez

Ricardo Frago Montanuy

The investigators want to study the effectiveness of prophylactic cholecystectomy in patients with midgut neuroendocrine tumor (jejunum, ileum or proximal colon) who require primary tumor surgery. When patients are diagnosed and are tributary to surgical treatment, the tumor might compromise vascularization, and patients need an extensive bowel resection. The patients might also receive medical treatment with somatostatin analogs. The combination of extensive bowel resection and medical treatment might increase gallbladder stones, but patients might not develop biliary stone disease, as in the general population, where 20% of the population have gallbladder stones but only a 10 to 15 % of the population will develop symptoms.

The idea comes from the lack of literature about the incidence of biliary Stone disease in patients with midgut NET tumors.

It's a multicentric, open-label and randomized clinical trial to evaluate the incidence of biliary stone disease in patients with midgut NET who require primary tumor surgery combined or not to cholecystectomy.

Our hypothesis suggests that patients with midgut neuroendocrine tumor who require primary tumor resection without the combination of prophylactic cholecystectomy do not have an increased incidence of biliary stone disease two years after the surgery, regardless of treatment with SSA.

Title: Effectiveness of prophylactic cholecystectomy in patients with midgut neuroendocrine tumor (jejunum, ileum or proximal colon) who require primary tumor surgery. Randomized, proof of concept clinical trial.

Background: The prevalence of midgut NET has increased due to advances in diagnostic tests and its indolent course. When patients are diagnosed, they might be tributary to surgical treatment requiring an extensive bowel resection, and medical treatment with somatostatin analogs. Both treatments are related with gallbladder stone formation. The ENETS and NANETs recommend prophylactic cholecystectomy in patients with midgut NET who require primary tumor surgery, However, there is a lack of scientific evidence reinforcing this recommendation.

Objectives: The main objective is to evaluate the cumulated incidence rate of biliary stone disease in patients with midgut NET who require primary tumor resection, two years after the surgery.

Design: It's a multicentric, open-label and randomized clinical trial. Patients will be recruited from the General Surgery Services of the six Hospitals participating in the study. Patients must fullfill inclusion and exclusion criteria.

It is expected to recruit a maximum of one hundred patients in two years (50 per group). Patients will be randomly assigned into the Experimental group (primary tumor resections) or Control group (primary tumor resections combined with cholecystectomy). The investigators will follow up patients until week 104 after surgery (8 visits).

Prophylactic Cholecystectomy in Midgut NETs Patients Who Require Primary Tumor Surgery.

Effectiveness of Prophylactic Cholecystectomy in Patients With Midgut Neuroendocrine Tumor (Jejunum, Ileum or Proximal Colon) Who Require Primary Tumor Surgery. Randomized, Proof of Concept Clinical Trial.

Incidence of biliary stone disease in patients with midgut NET who requiere primary tumor surgery

Postoperative complications according Clavien-Dindo classification

choledochal lithiasis or cholelithiasis according medical treatment

Gastrointestinal Quality of Life Index (GIQLY);Minimum value of 0 (the worst health state) and a maximum of 100 (best health state)

Health related Quality of life 15 D (HRQoL 15D);There are 15 areas with a minimum value of 0 (the worst health state) and a maximum of 100 (best health state) 15D

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Percutaneous Cholangiopancreatoscopy Registry	NCT05210322	Biliary Stones Cholangiocarcin... Biliary Strictu... Cholelithiasis Choledocholithi...	Percutaneous ch...	18 Years -	Johns Hopkins University
Percutaneous Cholangiopancreatoscopy Registry	NCT05210322	Biliary Stones Cholangiocarcin... Biliary Strictu... Cholelithiasis Choledocholithi...	Percutaneous ch...	18 Years -	Johns Hopkins University
Prophylactic Cholecystectomy in Midgut NETs Patients Who Require Primary Tumor Surgery.	NCT04735198	Midgut Carcinoi... Biliary Stones	Primary tumor s... Primary tumor s...	18 Years -	Hospital Universitari de Bellvitge
Prophylactic Cholecystectomy in Midgut NETs Patients Who Require Primary Tumor Surgery.	NCT04735198	Midgut Carcinoi... Biliary Stones	Primary tumor s... Primary tumor s...	18 Years -	Hospital Universitari de Bellvitge
Percutaneous Cholangiopancreatoscopy Registry	NCT05210322	Biliary Stones Cholangiocarcin... Biliary Strictu... Cholelithiasis Choledocholithi...	Percutaneous ch...	18 Years -	Johns Hopkins University

Spots Global Cancer Trial Database for biliary stones