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Pancrelipase

Pancreatin

Patient underwent a pancreas resection (whipple, distal pancreasectomy ...) with inclusion criteria. Criteria

Inclusion Criteria:

* Isolated pancreatic metastases from Colorectal cancer
* Previous surgery for colorectal cancer
* Surgically manageable lesions: duodenal-pancreatectomy surgical removal of metastatic repetitions in pancreas
* Other procedures:

total-pancreatectomy distal-pancreatectomy other metastases resection

* R0 resection
* no signs of peritoneal metastasis or tumor manifestations outside of the pancreas.
* CT Scan before surgery

Exclusion Criteria:

* metastases from different malignancies
* other malignancies
* surgically unmanageable lesions
* Multiple synchronous colorectal metastasis

Criteria

Inclusion Criteria:

* Isolated pancreatic metastases from Colorectal cancer
* Previous surgery for colorectal cancer
* Surgically manageable lesions: duodenal-pancreatectomy surgical removal of metastatic repetitions in pancreas

pancreaticoduodenectomy total-pancreatectomy distal-pancreatectomy other metastases resection

Pancreas surgery

Francesco Palmieri, MD

Francesco Lancellotti, MD

The aim of this study is to collect data from different centres to obtain a larger case series and enable a better definition of the outcomes after pancreatic metastasectomy from primary colorectal cancer. To evaluate the possible benefits of surgery, we intend to retrospectively analyze the outcome of patients in whom pancreatic metastases have been surgically treated.

Primary objective;

1. To evaluate feasibility and safety of pancreas resection in metastatic colorectal cancer
2. To evaluate oncological outcome at six months from surgical procedure

Secondary objective:

1. To evaluate oncological outcome at 12 months from surgical procedure

Metastases to the Pancreas are quite rare and account for less than 5% of pancreatic malignancies diagnosed in living patients.

In autopsy cases of malignant tumours, the incidence of pancreatic secondary tumours reaches 15%.

The metastases are predominantly of epithelial origin, most commonly from lung, stomach, small bowel, colon-rectum, kidney , breast , liver , ovary ,melanoma and urinary bladder.

It is largely described that resection of isolated metastasis to the lung or liver from primary tumour leads to improved survival; yet there is no consensus about the benefit of pancreas resection for metastases and the gold standard treatment is still not well defined.

The lack of data for pancreas metastases resections depends on low incidence and high perioperative risks. However, the improvement in morbidity and mortality rates after pancreaticoduodenectomy made the indication for this operation acceptable.

One of the larger series concluded that an aggressive surgical approach might be warranted if the patient can be rendered free of disease.

The majority of case series referred to renal cell carcinoma and resection for CCR are episodic. However there are several reports of solitary resected pancreatic metastases from colorectal cancer There is currently very limited experience with the surgical resection of isolated pancreatic colorectal metastases, and the role of surgery in the management of these patients is still debated.

To date, no prospective randomized or case-controlled studies have been performed to evaluate the role of surgical resection. Additionally, many of the existing retrospective studies are limited because of the small number of patients who were treated during prolonged periods of time.

Aim of the study The aim of this study is to collect data from different centres to obtain a larger case series and enable a better definition of the outcomes after pancreatic metastasectomy from primary colorectal cancer. To evaluate the possible benefits of surgery, the investigators intend to retrospectively analyze the outcome of patients in whom pancreatic metastases have been surgically treated.

The investigators launched the study aiming at demonstrating that pancreatic resection for colorectal metastases may be a safe and feasible procedure in selected patients and may provide long-term survival. The investigators sought to address the role of surgical resection and survival benefit from surgery. The investigators suppose to achieve a good prognosis with a median survival close to that observed after resection of hepatic metastases.

The guidelines for the treatment of colorectal cancer recommend resection of hematogenous metastases if they are deemed resectable.

Study design This study is an international multicenter retrospective cohort study to assess the outcomes of patients that underwent pancreas resection for solitary colorectal metastasis.

Aim of surgical interventions is to remove metastases in association to radical lymphadenectomy thus to achieve R0 result.

Patient data will be retrospectively analyzed and demographic characteristics, comorbidity status, clinical and radiological findings, treatment strategies , 30-day morbidity and mortality, oncological outcomes at 6 and 12 months will be evaluated.

Pancreas Resection for Colorectal Metastasis: Retrospective Study

Multicentre Retrospective Study on Pancreas Resection for Colorectal Cancer Metastasis

assessed by the number of patients with pancreas resection deceased within 30-days from the surgical intervention

assessed by the number of patients with pancreatic resection who experienced any type of postoperative complication within 30-days from the surgical intervention

6 moths survival 3. Survival : 6 moths survival 4. Disease free survival at 6 months

Ospedale Generale Di Zona Moriggia-Pelascini

MD, Principal investigator

Herbal and Botanical

Cola

Participants will be robotic surgeons in urologic, gynecologic, colorectal, hepatobiliary, gastric, and thoracic surgery

Surgeons will perform and participants will undergo robotic surgery according to the standard of care. No additional interventions will be performed on participating participants.

Robotic Surgery

Alvin Goh, MD

The purpose of this study is to develop new tools to understand surgeon performance to improve surgical training and participant outcomes after surgery.

Improving Surgeon Performance Measures for Robot-Assisted Surgery

Generalized Robotic Skills Assessment Using Machine Learning-Based Analysis Across Multiple Surgical Specialties

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

For the primary objective, we will capture Automated Performance Metrics/APMs and will determine the association between these and other metrics and surgeon experience, which will be used to construct validation.

APMs that will be used in the study:

Time Metrics

Camera Metrics

Instrument Metrics

System Metrics

Articulation Metrics

Memorial Sloan Kettering Cancer Center

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Cysts

Pancreatic Cyst

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Laparoscopic, robot-assisted, or hybrid resection

Minimally invasive pancreatoduodenectomy

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
Pancreas Resection for Colorectal Metastasis: Retrospective Study	NCT05714475	Pancreas Metast... Colorectal Canc...	Pancreas surger...	18 Years -	Ospedale Generale Di Zona Moriggia-Pelascini
Pancreas Resection for Colorectal Metastasis: Retrospective Study	NCT05714475	Pancreas Metast... Colorectal Canc...	Pancreas surger...	18 Years -	Ospedale Generale Di Zona Moriggia-Pelascini
Improving Surgeon Performance Measures for Robot-Assisted Surgery	NCT06037837	Surgery	Robotic Surgery	18 Years -	Memorial Sloan Kettering Cancer Center
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 pancreas surgery