Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Colorectal Neoplasms

Neoplasms, Second Primary

Liver Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplastic Processes

Liver Diseases

Hematinics

All Drugs and Chemicals

Herbal and Botanical

Liver Extracts

Cola

Resection of the primary colorectal carcinoma and liver metastases in two separate surgeries.

Resection of both the primary colorectal carcinoma and the liver metastases in one surgical procedure.

Patients randomized to staged resection will be operated according to the decision made by the tumor board meeting (liver or colorectal cancer first, based on tumor burden and symptoms), but both resections have to be done within a time period of 4-12 weeks.

Staged resection

In cases with simultaneous surgery, the liver resection is performed prior to colon resection in order to keep a low central venous pressure during the first part of the surgical procedure and to avoid congestion of the anastomosis line owing to possible Pringle manoeuvre.

Simultaneous resection

Sheraz Yaqub, MD PhD

Frida B Hansen

Sheraz Yaqub, MD, PhD

The SYLMET Trial is a randomized trial to compare simultaneous and two-staged resection of primary colorectal and synchronous liver metastases. This is an investigator-initiated, multicentre, randomized controlled trial to assess complications (primary endpoint), survival, cost-effectiveness, and quality of life (secondary endpoints).This trial will include patients with resectable primary tumour in the colon or upper rectum with less than five liver metastases that is possible to treat with surgical resection and/or ablation (RFA/MWA) at time of evaluation.

Colorectal cancer (CRC) represents the second most common cause of cancer and cancer death in Norway, and the incidence is increasing (Cancer in Norway, 2021, Cancer Registry of Norway). The liver is the most common site of metastasis from CRC. More than 4500 individuals are diagnosed with CRC in Norway each year, and approximately 20% of patients present with liver metastases at time of diagnosis (synchronous metastases). Resection of both the primary tumor and liver metastases is considered the only curative treatment, and has been shown to improve long-term survival, and is considered standard of care. However, the optimal timing of surgical resection of synchronous liver metastases in relation to the primary tumor is not well defined. Traditionally, staged resection has been preferred (i.e., resection of the primary tumour and liver metastases on separate admissions with a period of recovery between the two operations), whereas simultaneous resection is appealing (i.e., resection of both primary and metastases in one operative session). Despite a lack of randomized controlled trials comparing these two surgical approaches, the number of simultaneous resections has increased at several institutions. The evolvement of both liver and colorectal surgery in the last decades has led to reduced complications, making simultaneous resections more feasible. Previous retrospective cohort studies and meta-analyses suggest that simultaneous and staged approach carry similar postoperative complication and perioperative mortality rates as well as long-term survival. A recently published prospective observational study on staged or simultaneous surgery, reported similar outcomes in selected patients. To date, there is only one published randomized controlled trial which was aborted after inclusion of half of the sample size, after an accrual time of 10 years18. Due to lack of evidence, the majority of surgical societies worldwide still treats this patient group with staged resections, resulting in two hospital admissions, two rounds of general anaesthesia and surgery, and finally two episodes of postoperative recovery and rehabilitation. If this trial demonstrates that simultaneous surgery is safe, feasible, and cost-effective, it will potentially have a practice-changing impact worldwide.

Simultaneous vs. Staged Resection of Colorectal Cancer With Synchronous Liver Metastases

Simultaneous vs. Staged Resection of Colorectal Cancer With Synchronous Liver Metastases - A Multicentre Randomized Controlled Trial

The CCI is calculated as the sum of all complications that are weighted for their severity (multiplication of the median reference values from patients and physicians). The final formula yields a continuous scale to rank the severity of any combination of complications from 0 to 100 in a single patient.

Cost-effectiveness calculated by incremental cost effectiveness ratio (ICER)

Scale from 1 to 5. Higher score meaning more severe complication.

EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale range from -0.224 to 1; with 0, 1, and negative values corresponding to death, full health, and health states worse than death, respectively.

The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of multi-item scales and single items. Score from 1-100.

University of Oslo

Haukeland University Hospital

St. Olavs Hospital

Helse Stavanger HF

University Hospital, Akershus

Oslo University Hospital

Principal Investigator

Nervous System Diseases

Gland and Hormone Related Diseases

Adenoma

Pituitary Diseases

Pituitary Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Hypothalamic Diseases

Brain Diseases

Central Nervous System Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Hypothalamic Neoplasms

Supratentorial Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

the tumor abuting or displacing the hypothalamus in the preoperative MR images

hypothalamic involvement (the hypothalamus is no longer identifiable) in the preoperative MR images

Total resection of HIPA in a single surgery

Total resection

HIPA was resected subtotally at first time, and the tumor remnant was removed at a later date

HIPA was resected subtotally at first time, and the tumor remnant was controled by the stereotactic radiation therapy

Subtotal resection followed by stereotactic radiation therapy

Tao Huang, PhD, MD

Prospective and randomized evaluate efficiency and safety of different treatment strategies for hypothalamus-invading pituitary adenomas (HIPA)

There are various treatment strategies for hypothalamus-invading pituitary adenomas (HIPA), such as total resection (TR), subtotal resection with radiosurgery (STR+RS), etc. However,the optimal treatment of HIPA is still controversial. In this study, we want to evaluate the efficiency and safety of different treatment strategies in adults with HIPA.

Efficiency and Safety of Different Treatment Strategies in Adults With Pituitary Adenomas With Hypothalamic Involvement

EQ-5D will be evaluated before the first surgery and after the first surgery in 2 years

EQ-5D will be evaluated before the second intervention and after the second intervention in 3 months

Visual Acuity statue will be evaluated using Snellen's chart before the first surgery and after the first surgery in 2 years

Visual Field statue will be evaluated using a Humphrey visual field analyser before the first surgery and after the first surgery in 2 years

Whether the Hormone Replacement Therapy was used (Yes or No) before the first surgery and after the first surgery in 2 years

Volumetric analysis of tumor volume before the first surgery, intraoperatively and 3 months and 2 years after the first surgery will be performed. In addition, Tumor volume will be evaluated before the second intervention and intraoperatively. Gross total resection is defined as no tumor present in gadolinium enhanced T1 sequences.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Simultaneous vs. Staged Resection of Colorectal Cancer With Synchronous Liver Metastases	NCT06200831	Colorectal Canc... Colorectal Neop... Liver Metastasi... Liver Metastase...	Staged resectio... Simultaneous re...	18 Years - 80 Years	Oslo University Hospital
Efficiency and Safety of Different Treatment Strategies in Adults With Pituitary Adenomas With Hypothalamic Involvement	NCT04863456	Pituitary Adeno...	Total resection Staged resectio... Subtotal resect...	18 Years -	Wuhan Union Hospital, China

Spots Global Cancer Trial Database for staged resection