Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma

NCT ID: NCT06652672

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 341 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-12
• Study Completion Date: 2032-12-12

Brief Summary

The aim of this study is to reduce the need for colectomy and its' associated morbidity and mortality in patients with pT1-2 colon carcinoma after endoscopic resection and an estimated lymph node metastasis (LNM) risk of >15%, or with macroscopically suspected T1 tumors, by performing an endoscopic-assisted laparoscopic/robotic wedge resection of the tumor or scar, along with sentinel node (SLN) biopsy using indocyanine green (ICG). This intervention will be compared to the standard-of-care segmental resection using a partially randomized patient preference design. The primary outcome is the 3-year recurrence rate.

Detailed Description

Colorectal cancer is the third most common type of cancer in the Netherlands and the second leading cause of cancer-related deaths. An increased incidence of T1-2 tumors has been observed following the introduction of population screening programs, leading to more frequent endoscopic excisions. The risk of LNM in T1-2 colon cancers is relatively low. However, local excision does not allow assessment of lymph node status. Moreover, the diagnostic accuracy of computed tomography (CT) and other preoperative imaging modalities for detecting LNM remains limited.

Segmental colonic resections are associated with substantial morbidity. Based on large population-based datasets, 33% of patients experience at least one complication, including anastomotic leakage, with a postoperative mortality rate of 1.5-3.1%. Morbidity is known to substantially impact quality of life and contribute to a high economic burden. Additionally, major symptoms of low anterior resection syndrome (LARS) are present in 21% of patients after segmental resection, with reported effects on quality of life comparable to those experienced by patients who undergo rectal cancer resection and develop LARS.

To minimize unnecessary completion surgery, histopathological risk stratification is applied. In the Netherlands, histopathological risk factors for the presence of LNM in pT1-2 colon cancer are poor (high-grade) differentiation, lymphovascular invasion, high-grade tumor budding (Bd 2-3), and Haggitt level 4. The risk of LNM varies depending on the number of risk factors, pT stage, polyp morphology, and margin status. Completion segmental resection is omitted for pT1-2 tumors with a predicted LNM risk below 15%. Management is guided by risk stratification: for a 5-15% risk, active follow-up is preferred; for a 15-25% risk, active follow-up may be considered as an alternative to completion segmental resection through shared decision-making; and for a >25% risk, segmental resection is the preferred treatment. However, the vast majority of patients with a >15% risk of LNM who undergo surgery experience potential harm but no benefit, as they ultimately do not have LNM. Additionally, suspected T1 tumors are sometimes difficult or impossible to resect endoscopically. In such cases, wedge resection or segmental resection is the standard of care. Depending on T stage and other histopathological risk factors identified after wedge resection, a subsequent segmental resection may still be required. By adding SLN biopsy to the procedure, we aim to avoid the need for segmental resection after wedge resection.

The investigators hypothesize that, in patients who have undergone R0/R1/Rx endoscopic resection of T1-2 colon cancer and have a >15% risk of LNM, or in those with macroscopically suspected T1 tumors, an SLN biopsy combined with wedge resection of the residual tumor or scar can safely spare the majority of patients with negative SLNs from undergoing segmental resection. In our systematic review and meta-analysis, we found a pooled accuracy of 98% and a sensitivity of 80% for SLN detection in T1-2 colon cancer. The investigators use endoscopic submucosal injection of ICG at the tumor site, which carries a low risk of intra-abdominal spillage that could hinder SLN identification.

The SLN biopsy will be combined with an endoscopy-assisted wedge resection of the tumor or scar following endoscopic resection. During the endoscopy-assisted wedge resection, the surgeon first identifies and mobilizes the colon to facilitate the wedge resection. A gastroenterologist then performs a colonoscopy to visualize the scar from the previously resected tumor. With intraluminal endoscopic visualization, the surgeon places a suture to provide traction and position the linear stapler. The gastroenterologist confirms complete inclusion of the scar and ensures lumen patency before the stapler is fired. Endoscopy-assisted limited wedge resection is associated with low complication rates and is performed at lower cost compared to laparoscopic segmental resection. Because no anastomosis is created, the risk of anastomotic leakage is eliminated. This approach could reduce morbidity, mortality, hospital stay, and stoma rates. Although staple line failure and leakage are theoretical risks, such complications have not been reported in previous cases.

Patients with a positive SLN (macro- or micrometastasis) or T3-4 tumors are offered segmental resection. Node-positive patients are recommended to undergo adjuvant chemotherapy if performance status allows. SLN-negative patients do not undergo further surgery and are managed with an intensive follow-up strategy. Assuming 80% sensitivity and a 20% prevalence of lymph node metastasis, the risk of retained positive nodes after SLN biopsy is approximately 4%. Additionally, tumor deposits (TDs) could potentially be missed when patients are treated with SLN biopsy and wedge resection. However, only 0.45% of patients with stage I disease are TD-positive. The investigators consider the absolute risks of missed lymph node metastases and TDs acceptable, given the reduced perioperative morbidity and mortality associated with segmental resection.

The SENTRY trial will be the first to offer organ-sparing surgery combined with an SLN biopsy for patients with selected early-stage colon cancer. This organ-sparing approach is anticipated to improve postoperative mortality, morbidity, hospital stay, quality of life, and costs compared to standard segmental resection, without compromising oncologic outcomes. This multicenter, partially randomized, patient-preference trial will compare the organ-sparing approach with standard-of-care segmental resection to assess oncologic safety.

Conditions

Colon Cancer; Colon Adenocarcinoma; Sentinel Lymph Node; Sentinel Lymph Node Biopsy; Colon Neoplasms; Colon Neoplasm; Fluorescence; Fluorescence Guided Surgery; Fluorescence Laparoscopy; Fluorescence-guided Resection; Colon Surgery; Indocyanine Green (ICG)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Organ-sparing surgery

Local resection with sentinel lymph node biopsy

Group Type: EXPERIMENTAL

Organ-sparing surgery

Intervention Type: PROCEDURE

Endoscopy-assisted laparoscopic/robotic wedge resection and sentinel lymph node biopsy using submucosal injection of ICG.

Standard of care segmental resection

Group Type: ACTIVE_COMPARATOR

Standard of care segmental resection

Intervention Type: PROCEDURE

Standard of care segmental resection of the affected part of the colon including removal of regional lymph nodes.

Interventions

Organ-sparing surgery

Endoscopy-assisted laparoscopic/robotic wedge resection and sentinel lymph node biopsy using submucosal injection of ICG.

Intervention Type: PROCEDURE

Standard of care segmental resection

Standard of care segmental resection of the affected part of the colon including removal of regional lymph nodes.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Oral and written informed consent (IC)
• Aged 18 years and older
• Fit for both organ-sparing surgery and colectomy
• Pathologically confirmed T1-2 adenocarcinoma of the colon following R0, R1, or Rx endoscopic resection with an estimated LNM risk >15% (Table 5.2.2. in module 5.2 of the Dutch CRC guideline); or a lesion macroscopically suspected to be (deep-invasive) T1 colon cancer, measuring <40 mm, for which wedge resection is considered the most suitable local resection technique as recommended by the MDT
• The resection scar after local excision is expected to be clearly recognized at endoscopy, either by a tattoo or by detecting a scar in the colorectal segment where no other polypectomies were performed
• Lesion located >25cm from the anus based on endoscopic measurement, or above sigmoid take-off

Exclusion Criteria

• Patients who opt for active follow-up instead of surgery following shared decision-making
• Distant metastasis
• Lynch syndrome
• Another active malignancy requiring palliative treatment at the time of colon cancer diagnosis
• Previous colorectal cancer within the last 5 years
• Tumours that comprised >50% of the colon circumference before resection
• Tumours involving the ileocaecal valve
• Pregnancy, lactation or a planned pregnancy during the course of the study
• Known allergy to any of the compounds used for SLN identification (ICG, Iodine or Sodium iodide)
• Previous colonic surgery (excluding appendectomy)
• Contra-indication for laparoscopic or robotic surgery
• Severe kidney- or liver failure
• Hyperthyroidism or an autonomously functioning thyroid adenoma

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meander Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Esther Consten

Prof. dr. Esther Consten

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank J Voskens

Role: PRINCIPAL_INVESTIGATOR

Meander Medical Center

Locations

Meander Medisch Centrum

Amersfoort, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Bart CT van de Laar

Role: CONTACT

bct.vande.laar@meandermc.nl

+31338507137

Facility Contacts

Bart CT van de Laar, MD

Role: primary

bct.vande.laar@meandermc.nl

+31338507137

Other Identifiers

NL84875.100.23

Identifier Type: OTHER

Identifier Source: secondary_id

NL84875.100.23

Identifier Type: -

Identifier Source: org_study_id