Clinical trial · Interventional
Lateral Pelvic Lymph Node Dissection for Rectal Neuroendocrine Neoplasms Undergoing Laparoscopic Total Mesenteric Excision
NCT06279299CI-TRIAL-00074419recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to investigate the metastatic status of lateral pelvic lymph nodes in rectal neuroendocrine neoplasms (rNENs) undergoing laparoscopic total mesenteric excision (TME). The hypothesis is that the rate of lateral lymph node metastasis is underestimated in rNENs undergoing TME, necessitating concurrent lateral Pelvic lymph node dissection.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Neuroendocrine Neoplasm | Rectal Neuroendocrine Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lateral pelvic lymph node dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lateral Pelvic lymph node dissection
- description
- After performing TME surgery, further conduct lateral pelvic lymph nodes dissection.
- interventionNames
- Procedure: lateral pelvic lymph node dissection
Primary outcomes (1)
- measure
- The rate of lateral pelvic lymph node metastasis
- timeFrame
- up to 14 days
- description
- The rate of lateral pelvic lymph node metastasis = lateral pelvic lymph node metastasis cases/all cases.
Secondary outcomes (5)
- measure
- The rate of lymph node metastasis
- timeFrame
- up to 14 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Biopsy proven rectal neuroendocrine neoplasm (neuroendocrine tumor and carcinoma); 2. Meets any one of the following conditions: * Preoperative imaging examinations reveal that the maximum diameter of the tumor is greater than 2cm. * Preoperative imaging examinations reveal that the maximum diameter of the tumor is between 1-2cm and the clinical staging is T2 or higher. * Preoperative imaging examinations reveal that the maximum diameter of the tumor is between 1-2cm and is categorized as Grade 3 differentiation. * Recurrence after local excision under endoscopy. 3. Eastern Cooperative Oncology Group(ECOG) performance score ≤ 1; 4. Written informed consent; Exclusion Criteria: 1. Complete intestinal obstruction; 2. Hepatitis activity and peripheral neuropathy (such as peripheral neuritis, pseudo meningitis, motor neuritis, and sensory impairment); 3. Significant organ dysfunction or other significant diseases, including clinically relevant coronary artery disease, cardiovascular disease, or myocardial infarction within the 12 months before enrollment; severe neurological or psychiatric history; severe infection; active disseminated intravascular coagulation; 4. Pregnancy or breastfeeding; 5. Alcohol abuse or drug addiction; 6. Concurrent uncontrolled medical condition;
References
Publications (0)
Data not yet available
No reference posted for this study.