Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Adenocarcinoma

Neoplasm Metastasis

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplastic Processes

Gastrointestinal Agents

All Drugs and Chemicals

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

Gland and Hormone Related Diseases

Rare Diseases

Pancreatitis

Pancreatic Neoplasms

Pancreatic Diseases

Endocrine Gland Neoplasms

Endocrine System Diseases

Pancreatic Cancer

Patients who will not receive intraperitoneal drainage following pancreas resection.

Patients who will receive drains, the standard of care treatment, following pancreas resection.

A closed-suction drain will not be placed near the transection margin at the time of surgery in the experimental group.

No Drains

A drain will be placed near the pancreatic transection margin at the time of surgery (standard of care).

Drains

William E Fisher, MD

This randomized prospective trial is designed to test the hypothesis that pancreatectomy without routine intraperitoneal drainage does not increase the severity or frequency of complications within 60 days of surgery.

The rate of pancreatic fistula after pancreas resection is about 10% and surgeons have traditionally placed drains near the pancreatic anastomosis to control this potentially very serious complication. In recent years, advances in interventional radiology have allowed safe percutaneous drainage of intra-abdominal fluid collections. Some surgeons have abandoned the routine use of prophylactic drains placed at the time of pancreas resection and rely on percutaneous drainage for the minority of patients who develop a pancreatic fistula.

Hypothesis:

This randomized prospective trial is designed to test the hypothesis that pancreatectomy without routine intraperitoneal drainage does not increase the severity or frequency of complications within 60 days of surgery. The primary endpoint to assess the severity of complications will be the number of patients with any ≥ Grade II complication. Severity of complications experienced will also be assessed by comparing the number of patients with, any ≥ Grade III complication, any serious adverse event (SAE), and the median complication severity grade of all complications. The frequency of complications will be assessed by comparing the number of patients with 1, 2, 3, 4, 5, or more than 5 complications of any severity grade.

Objectives:

Primary: Difference in 60-day ≥ Grade II complication rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

Secondary:

A. 60-day ≥ Grade III complication rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

B. Serious adverse event (SAE) rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

C. Median complication severity grade comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

D. 60-day frequency of complications (any Grade) between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

E. 60-day, and 90-day mortality rate comparison between patients who receive a pancreatetomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

F. Rate of specific complications compared between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

G. Length of stay (index admission and total within 60 days) comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

H. Crude cost comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

I. Quality of life comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

Pancreas Resection With and Without Drains

A Randomized Prospective Multicenter Trial of Pancreas Resection With and Without Routine Intraperitoneal Drainage

The primary outcome measure was defined as the number of patients with grade 2 or higher grade complications within 60 days of the date of surgery will be meticulously recorded using specific and standardized definitions. Complications will be graded in severity using the Common Terminology Criteria for Adverse Events CTCAE (v4.0) (Grade 1-5) unless otherwise stated below. For grading schemes with A, B, C rather than 1-5, severity scores will be converted to 1-3.

This secondary outcome measure was defined as the number of patients with one or more complications with grade 3 or higher grade within 60 days of the date of surgery. Complications will be graded in severity suing the Common Terminology Criteria for Adverse Events, CTCAE(v4.0) (Grade 1-5). For grading schemes with A, B, C rather than 1-5, severity scores will be converted to 1-3.

This secondary outcome measure is the number of patients with one or more SAE within 60 days of the date of surgery. This outcome will be presented in the Adverse Event Module. The total number of patients affected were 344 (# of no drain=170 vs # of drain=174) and two patients were experienced the serious adverse event (SAE) defined by the protocol. Refer to the Adverse events tables for specifics.

This will be calculated for all patients and among just the patients who experienced complications. The complication will be graded in severity using the Common Terminology Criteria for Adverse Events, CTCAE (v4.0) and the severity grade is from 1 to 5. The outcome measure is the median of the Sum of the complication grades of each complication experienced by the patient/# of complications experienced

This is the median number of complications per patients.

The outcome measure is the number of patients with each particular complication but not including serious adverse events. The complication is using using the Common Terminology Criteria for Adverse Events CTCAE (v4.0).

This is the median of length of stay for the index admission. An index admission is an admission in a hospital with a principal diagnosis of a specified condition that meets the inclusion and exclusion criteria for that measure. Total days in the hospital within 60 days of surgery was not collected for analysis. Only length of stay for the index admission was reported.

This is the crude cost of subsequent procedures (CT scan, paracentesis, percutaneous drainage, reoperation) and the length of the index admission and any subsequent readmission. Data were not collected for analysis.

Subjects will complete the FACT-PA quality of life instrument and the results will be recorded. The quality of life scores at 30 days was collected for analysis.

The Functional Assessment of Cancer Therapy-Pancreatic Cancer (FACT-PA), is a self-administered pancreas-specific health status survey. The instrument is scored on a scale of 0-28 for Physical well-being subscale(PWB), Social/Family well-being subscale(SWB), Functional well-being subscale(FWB), and on a scale of 0-24 for Emotional well-being subscale(EWB), and on a scale of 0-36 for additional condition of FACT-PA (FACT-PA subscale). The total FACT-G score is the sum of PWB, SWB, FWB, and EWB and the range of 0\~108. The total FACT-PA score is the sum of the total FACT-G score and FACT-Pa subscale and the range of 0\~144. A lower score represents the worst quality of life.

Baylor College of Medicine

Director, Elkins Pancreas Center, Professor, Michael E. DeBakey Department of Surgery

Patients did not receive intraperitoneal drainage following pancreas resection.

No Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group.

Patients did receive drain(s), the standard of care treatment, following pancreas resection.

Drains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care).

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

A potential weakness of the current study is that it took 5 years to reach targeted accrual.

Amy McElhany, Clinical Research Manager

the study is powered to be able to detect a 15% difference in the ≥ Grade II complication rate between the drain and no drain groups. A total of 342 evaluable patients will be needed for the two study groups (n=171 per group) in order to achieve 80% power to detect a 15% increase or decrease in the complication rate with a significance level of 0.05.

60-day ≥ Grade II Complication Rate

60-day ≥ Grade III Complication Rate

Serious Adverse Event (SAE) Rate

All patients

For just the patients with complications

Median Complication Severity Grade

60-day Frequency of Complications

90-day Mortality Rate

Pancreatic_leak_fistula

Postoperative_Abdominal_FluidCollection

Biliary_leak

Enteric_leak

Lymph_Leak

Diarrhea

Gastroparesis_DelayedGastricEmptying

SmallBowelObstruction

Seroma

Intra_abd_abscess

Wound_Dehiscence

Wound_Infection

Fever

Patients who will not receive intraperitoneal drainage following pancreas resection.

No Drains: A closed-suction drain will not be placed near the transection margin at the time of surgery in the experimental group.

Patients who will receive drains, the standard of care treatment, following pancreas resection.

Drains: A drain will be placed near the pancreatic transection margin at the time of surgery (standard of care).

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
Pancreas Resection With and Without Drains	NCT01441492	Pancreas Tumor Pancreatitis	No Drains Drains	18 Years -	Baylor College of Medicine
Pancreas Resection With and Without Drains	NCT01441492	Pancreas Tumor Pancreatitis	No Drains Drains	18 Years -	Baylor College of Medicine

Spots Global Cancer Trial Database for pancreas resection