Neoplasms

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Rare Diseases

Cholangiocarcinoma

Adenocarcinoma

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Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

Whipple or pylorus preserving pancreatoduodenectomy following minimally invasive approach (laparoscopic or robotic). Hybrid (hand assisted) precedures will be included in the minimally invasive cohort.

Whipple or pylorus preserving pancreatoduodenectomy following open (laparotomy) approach.

Whipple's procedure using minimally invasive (laparoscopic/robotic) techniques

Minimally invasive pancreatoduodenectomy

Moh'd Abu Hilal, MD, PhD

Outcomes for minimally invasive and open pancreatoduodenectomy for distal cholangiocarcinoma have not been compared. This is an international multicenter propensity score matched cohort study including patients after MIPD or OPD for dCCA. Primary outcomes included overall survival (OS) and disease-free interval (DFI).

This study is an international multicenter propensity score matched cohort study using the database of the International Study Group on non-pancreatic periAmpullary CAncer, the ISGACA consortium (www.isgaca.com), including all patients who underwent a pancreatoduodenectomy for non-pancreatic periampullary cancer. Data will be retrospectively collected. To minimize differences between groups, all the participating centers perform both OPD and MIPD and all centers meet the Miami guideline minimum volume of at least 20 MIPD per year. This study is approved by all the locals Ethical Committees (approval number from the promoting center, Comitato etico di Brescia, NP 5318 - 01.06.2022) and it will be performed according to the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE guideline and checklist), and the Declaration of Helsinki.

Minimally Invasive Pancreatoduodenectomy for Distal Cholangiocarcinoma

Surgical and Oncological Outcome After Minimally Invasive and Open Pancreatoduodenectomy for Distal Cholangiocarcinoma: an International Propensity Score Cohort Study

Upon reasonable request it would be possible to share data.

Time-to-event data, months + occurrence of event (death or recurrence)

Fondazione Poliambulanza Istituto Ospedaliero

Digestive System Diseases

Gland and Hormone Related Diseases

Symptoms and General Pathology

Pancreatic Neoplasms

Cysts

Pancreatic Cyst

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

Laparoscopic, robot-assisted, or hybrid resection

Open pancreatoduodenectomy

RATIONALE: Minimally-invasive pancreatoduodenectomy (MIPD), either laparoscopic or robot-assisted, has been suggested as a valuable alternative to open pancreatoduodenectomy (OPD). The generalizability of the current literature is, however, unknown since randomized studies are lacking, and current data are published from few, very high volume centers and selection bias with a lack of case-matched series. International studies are lacking completely.

OBJECTIVE: To compare outcomes of MIPD versus open pancreatoduodenectomy (OPD), in high-volume European pancreas centers (\>10 MIPDs per year, total \>20 PDs per year).

METHODS: A retrospective multicenter propensity-score matched cohort study including all consecutive patients who underwent MIPD (or MI total pancreatectomy) between January 2012 and December 2016, for pancreatic head, bile duct, or duodenal cancer or cysts except chronic pancreatitis. Predefined electronic case report forms will be disseminated amongst participating centers. Participants are responsible for their own data collection. Matching of MIPD cases (collected from participating centers) to OPD controls (extracted from Dutch and German national registries) will be based on propensity scores determined by logistic regression including preoperative variables: year of surgery, demographics, BMI, ASA, comorbidities, tumor size, tumor etiology (diagnosis), and multivisceral resection. Primary outcome is 90-day major morbidity(Clavien-Dindo ≥ 3a). Secondary outcomes are 90-day postoperative events including: pancreatic fistula, length of hospital stay, R0 (microscopically negative) resection margin, malignant lymph node ratio, days to adjuvant therapy and overall survival.

A Pan-European Study on Minimally Invasive Versus Open Pancreatoduodenectomy in High-volume Centers

Outcomes After Minimally Invasive or Open Pancreatoduodenectomy in High-volume Centers; a Pan-European Retrospective Propensity-score Matched Cohort Study

Resection to adjuvant chemo(-radio) therapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Minimally Invasive Pancreatoduodenectomy for Distal Cholangiocarcinoma	NCT05478889	Distal Cholangi...	Minimally invas...	18 Years -	Fondazione Poliambulanza Istituto Ospedaliero
Minimally Invasive Pancreatoduodenectomy for Distal Cholangiocarcinoma	NCT05478889	Distal Cholangi...	Minimally invas...	18 Years -	Fondazione Poliambulanza Istituto Ospedaliero
A Pan-European Study on Minimally Invasive Versus Open Pancreatoduodenectomy in High-volume Centers	NCT03172572	Pancreatic Neop... Pancreas Cyst Pancreas Cancer	Minimally invas... Open pancreatod...	18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Spots Global Cancer Trial Database for minimally invasive pancreatoduodenectomy