Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Primary Liver Cancer

Hematinics

All Drugs and Chemicals

Liver Extracts

ICG molecular fluorescence imaging will be used in local hepatectomy of primary liver cancer in this group

ICG molecular fluorescence imaging will not be used in local hepatectomy of primary liver cancer in this group

ICG will be injected to participants preoperatively for molecular fluorescence image

Indocyanine green for injection

Chihua Fang, MD

Xiaojun Zeng

Chihua Fang, M.D

The of this study is to explore the clinical outcomes of indocyanine green molecular fluorescence imaging in local resection of primary hepatocellular carcinoma (CNLC Ⅰa stage).

Indocyanine green molecular imaging technique is often used in the surgical treatment of primary liver cancer. Its application in hepatectomy of primary liver cancer is currently in the stage of case accumulation and clinical research. No prospective study has been conducted to determine the clinical efficacy of indocyanine green molecular imaging for local hepatectomy of primary liver cancer. On the basis of more than 1000 liver resection procedures, the investigators want to apply indocyanine green molecular imaging technology, a cheap, simple and radiation-free method, to guide surgical resection. The purpose is to assist surgical procedures and improve participants' tumor-free survival.

Indocyanine Green Molecular Fluorescence Imaging Technique Using in Diagnosis and Treatment of Primary Liver Cancer

Multicenter Randomized Controlled Clinical Trial of Indocyanine Green Molecular Fluorescence Imaging in the Diagnosis and Treatment of Primary Liver Cancer

No tumor recurrence within 3 years after surgery divided by total number of patients

Compare positive margin rate in both groups

Compare negative margin rate in both groups

The shortest distance between tumor and resection margin was compared between the two groups by pathological diagnosis

Compare intraoperative blood loss in both groups

Compare intraoperative blood transfusion volume in both groups

Small lesions detected by ICG fluorescence and confirmed by pathology in the intervention group

The number of residual tumors confirmed by ICG fluorescence detection at the liver margin of the intervention group

The number of cases of successful intraoperative detection of biliary fistula by fluorescence in the intervention group divided by the total number of cases in the intervention group.

The number of extrahepatic metastases of primary liver cancer detected by ICG and confirmed by pathology in the intervention group

Compare Postoperative hospital stay in both groups. Eg: Postoperative hospital stay is the number of days from the day of surgery to the day of discharge.

Compare the levels of Alanine aminotransferase on postoperative days 1, 3, and 5 in both groups

Compare the levels of Aspartate aminotransferase on postoperative days 1, 3, and 5 in both groups

Compare the levels of serum albumin on postoperative days 1, 3, and 5 in both groups

Compare the levels of total bilirubin on postoperative days 1, 3, and 5 in both groups

Compare hemoglobin on postoperative days 1, 3, and 5 in both groups

Compare platelets on postoperative days 1, 3, and 5 in both groups

Compare prothrombin time on postoperative days 1, 3, and 5 in both groups

Perioperative death was defined as death occurring within 90 days after surgery

Zhujiang Hospital

Clinical Professor

Skin and Connective Tissue Diseases

Rectal Neoplasms

Gastrointestinal Stromal Tumors

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Antineoplastic Agents

Amino Acids

Imatinib Mesylate

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Following the attainment of the maximum treatment response through imatinib mesylate administration, typically occurring within 6-12 months, as evidenced by two consecutive imaging evaluations, the tumor exhibited no further reduction in size, thus necessitating the selection of surgical intervention.

According to the characteristics of the location of the tumor, the surgeon decides the surgical approach based on the existing literature and the availability of surgical equipment, including:

1. Local transanal resection (TA)
2. Local resection transsacralapproach
3. Local resection via perineal approach
4. Local resection transvaginal approach

1. For patients with c-KIT exon 11 mutation, imatinib mesylate, 400mg, qd.
2. For patients with c-KIT exon 9 mutation, imatinib mesylate, 600mg or 800mg, qd.

According to the characteristics of the location of the tumor, the surgeon decides the surgical approach based on the existing literature and the availability of surgical equipment, including:

1. Local transanal resection (TA)
2. Local resection transsacralapproach
3. Local resection via perineal approach
4. Local resection transvaginal approach

Local resection

Weizhong Jiang, MD

Jiabin Zheng

Prior to the implementation of preoperative imatinib mesylate therapy, a considerable percentage (ranging from 34.5% to 67.5%) of individuals diagnosed with rectal gastrointestinal stromal tumors (GIST) underwent abdominoperineal resection (APR), a surgical procedure that involved the removal of the anus and necessitated a permanent colostomy.

This study aims to investigate the safety and viability of an organ-preserving approach involving preoperative imatinib mesylate treatment in conjunction with local resection for rectal GIST, specifically targeting patients with c-KIT gene mutations.

Prior to the implementation of preoperative imatinib mesylate therapy, a considerable percentage (ranging from 34.5% to 67.5%) of individuals diagnosed with rectal gastrointestinal stromal tumors (GIST) underwent abdominoperineal resection (APR), a surgical procedure that involved the removal of the anus and necessitated a permanent colostomy.

Previous studies have established that preoperative administration of imatinib mesylate effectively diminishes the size of rectal gastrointestinal stromal tumors (GIST) and enhances the likelihood of sphincter preservation. After initiating preoperative imatinib mesylate treatment, the sphincter preservation rate has notably escalated from 4.2% to 33.0%-94.9%.

In theory, lymph node resection is not required for Gastrointestinal Stromal Tumors (GIST); the local excision of rectal GIST enables sphincter preservation and yields satisfactory anal function and quality of life (QoL). Various surgical techniques are utilized for local excision, including traditional transanal (TA) and transanal minimally invasive surgery (TAMIS) approaches.

This study aims to explore the safety and feasibility of an organ-preservation strategy of preoperative imatinib mesylate combined with local resection in rectal gastrointestinal stromal tumor (GIST), specifically for patients with c-KIT gene mutations.

Preoperative Imatinib Mesylate Combined With Rectal-sparing Surgery in Patients With c-KIT Gene-mutant Rectal GIST

Preoperative Imatinib Mesylate Combined With Rectal-sparing Surgery in Patients With c-KIT Gene-mutant Rectal GIST: an Open-label, Single-arm, Phase III Trial（PIRKER）

Rectum intact, owing to no total mesorectal excision (TME), no locoregional regrowth unless amenable to limited, curative (R0) salvage surgery by local excision (LE) and no permanent stoma (including a never reversed protective stoma, or a stoma owing to toxicities and/or poor functional outcomes)

The proportion of participants who remain disease-free at 3 years after surgery

The local recurrence rate is defined as the incidence detection of a tumor involving the bowel wall only that occurs after LE or TME

The proportion of participants who remain survival at 3 years after surgery

The R0 resection rate is defined as the rate of R0 resection

Quality of life accessed by EORTC-QLQs-C30 and EORTC-QLQs-CR29 questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Indocyanine Green Molecular Fluorescence Imaging Technique Using in Diagnosis and Treatment of Primary Liver Cancer	NCT05160740	Liver Cancer	Indocyanine gre...	18 Years - 66 Years	Zhujiang Hospital
Preoperative Imatinib Mesylate Combined With Rectal-sparing Surgery in Patients With c-KIT Gene-mutant Rectal GIST	NCT05970900	Gastrointestina...	Imatinib Mesyla... Local resection	18 Years - 80 Years	Fujian Medical University Union Hospital
Indocyanine Green Molecular Fluorescence Imaging Technique Using in Diagnosis and Treatment of Primary Liver Cancer	NCT05160740	Liver Cancer	Indocyanine gre...	18 Years - 66 Years	Zhujiang Hospital
Indocyanine Green Molecular Fluorescence Imaging Technique Using in Diagnosis and Treatment of Primary Liver Cancer	NCT05160740	Liver Cancer	Indocyanine gre...	18 Years - 66 Years	Zhujiang Hospital

Spots Global Cancer Trial Database for local resection