Robotic vs Laparoscopic D3-D4 Lymphadenectomy for Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Robotic Versus Laparoscopic D3-D4 Lymphadenectomy for Patients With Advanced Colorectal Cancer… A Randomized Prospective Clinical Trial for the Comparison of Oncologic and Functional Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05961423
• Other study ID #: 202002011RINB
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2020
• Est. completion date: May 1, 2024

Study information

• Verified date: April 2023
• Source: National Taiwan University Hospital
• Contact: Jin-Tung LIANG, PhD
• Phone: 886-9-72651432
• Email: jintung[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Approximately one third of patients with colorectal cancer are diagnosed as locally advanced stage with metastasis to N3 - N4 lymph nodes requiring a D3 - D4 lymphadenectomy. Our previous study has indicated that, by laparoscopic approach, the extended abdomino-iliac lymphadenectomy, the so-called D3-D4 lymph node dissection, could be performed with quick convalescence and similar oncologic efficacy for the treatment of advanced recto-sigmoid cancer with metastatic lesions over N3-N4 lymph nodes, as compared with traditional open surgery. In the present study, the investigators will further compare the oncologic and functional outcomes of robotic versus laparoscopic approach in performing such challenging surgical procedures for patients with advanced colorectal cancer requiring a D3-D4 lymphadenectomy through a randomized prospective clinical trial.

Description:

Approximately one third of patients with colorectal cancer are diagnosed as locally advanced stage with metastasis to N3 - N4 lymph nodes requiring a D3 - D4 lymphadenectomy. Our previous study has indicated that, by laparoscopic approach, the extended abdomino-iliac lymphadenectomy, the so-called D3-D4 lymph node dissection, could be performed with quick convalescence and similar oncologic efficacy for the treatment of advanced recto-sigmoid cancer with metastatic lesions over N3-N4 lymph nodes, as compared with traditional open surgery. In the present study, the investigators will further compare the oncologic and functional outcomes of robotic versus laparoscopic approach in performing such challenging surgical procedures for patients with advanced colorectal cancer requiring a D3-D4 lymphadenectomy through a randomized prospective clinical trial. In the upcoming three years (2020/4/1-2023/3/31),consecutive recto-sigmoid cancer patients with metastasis to para- aortic lymph node will be screened and randomized to patient groups undergoing either robotic or laparoscopic D3-D4 lymph node dissection. The extent of D4 lymph node dissection includes extirpation of the extra-mesenteric lymphatic basin along bilateral common iliac arteries and veins, inferior vena cava, and abdominal aorta upward to the level just below the duodenal third portion and left renal vein, besides the traditional mesenteric dissection of paracolic (N1) lymph nodes, intermediate (N2) mesenteric lymph nodes, and lymph nodes around the root of inferior mesenteric artery (N3). The harvested lymph nodes were mapped and managed according to the Japanese guidelines. The metrics of surgical outcomes included: the number of harvested lymph nodes; time to recurrence of cancer after surgery; the length of operation time; blood loss; intra-operative and post-operative complications; and wound size. Functional recovery was evaluated by length of post-operative flatus passage, the restoration of urinary function, hospitalization, and degree of post-operative pain. A subjective-response standardized questionnaire was given to patients to assess disability, which included the number of days until return to partial activity, full activity, and work. Since the current randomized prospective study in this field is still lack of, the investigators believe that this study will be of academic importance. And, clinically, the presented study can to help set up the standard operation procedures for such patient, and provide the level one evidence for National Health Insurance Administration in evaluating the reimbursement of HTA (high technology assessment) procedures.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 286
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Histopathologically proved adenocarcinoma located at upper rectum (above pelvic peritoneal reflection), recto-sigmoid junction, or distal sigmoid colon (generally 10 to 25 cm above anal verge). Only recto-sigmoid cancers above the peritoneal reflection were investigated because the lymphatic drainage of upper rectum and distal sigmoid colon was along the inferior mesenteric artery to the para-aortic area, and therefore the extent of surgical resection and lymph node mapping were standardized.
• Clinically TNM stage III cancers.
• Curative robotic or laparoscopic surgery.
• American Society of Anesthesiology (ASA) class I to III patients.
• Age between 50 and 75 years. This was because patients >50 years old are generally deemed to be over the reproductive age, and the D3 dissection was considered too aggressive for patients older than 75 years.
• Patients who are willing to receive minimally invasive surgical procedures to treat their rectosigmoid cancer.

Exclusion Criteria:

• Tumors located at other anatomic positions;
• Emergency or palliative surgery;
• Evidence of disseminated disease or adjacent organ invasion;
• Primary tumor mass =8 cm in diameter;
• Morbidly obese patients (body mass index =40 kg/m2);
• Previous major surgery of lower abdomen.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• Robotic surgery
The patient group undergoing robotic surgery for the treatment of locally advanced colorectal cancer

Locations

Country	Name	City	State
Taiwan	Jin-Tung LIANG	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time to recurrence of cancer after curative resection	The duration between the time of curative resection and the time to cancer recurrence	Up to 3 years
Secondary	the number of dissected lymph nodes	The total numbers of lymph node harvested during the operation	An average of 7 days
Secondary	The distribution of dissected lymph nodes	The total numbers of lymph node harvested in different lymph node area during the operation	An average of 7 days
Secondary	Functional recovery	Functional questionnaire regarding fecal continence and bowel function will be completed by an assistant not aware of the randomization status of the patient right after completion of the manometric studies. Continence was recorded as Grade 1 (perfect continence), Grade 2 (incontinence of flatus), Grade 3 (occasional minor soiling), Grade 4 (frequent major soiling), and Grade 5 (total incontinence).	Up to 6 months
Secondary	The overall costs of both minimally invasive surgical approaches	The total medical costs including medication fee and equipment fee are recorded.	Through patients' discharge from hospital, an average of 7 days
Secondary	Assessment of disability	The time for the patients after the operation to resume partial activity, full activity, and return to work will be recorded to evaluate the disability.	12 months