Abstract:BackgroundLow rectal cancer surgery without anus conservation needs permanent ileostomy or colostomy which seriously affects the quality of life of patients. Therefore, low rectal cancer surgery not only pays attention to the safety of surgical treatment but also to the anus conservation.MethodsSixty-seven patients suffering from low rectal cancer had undergone laparoscopic surgery which was analyzed through retrospective study. They were divided into the anus-conserving and non-anus-conserving groups. Thirty-… Show more
“…3 ) [ 13 , 23 , 25 , 26 ] (l) Angle T4 The angle between the upper and lower borders of the pubic symphysis with the lower border of the tumor as the vertex (Fig. 4 ) [ 31 ] (m) Angle A5 The angle between the line connecting the upper and lower borders of the pubic symphysis and the line connecting the midpoint of the upper border of the pubic symphysis to the sacral promontory (Fig. 1 ) [ 16 ] Fig.…”
Due to the fixed bony structure of the pelvis, the pelvic operation space is limited, complicating the surgical operation of rectal cancer, especially middle and low rectal cancer. The closer the tumor is to the anal verge, the smaller the operative field and operating space, the longer the operative time, and the greater the incidence of intraoperative side injuries and postoperative complications. To date, there is still no clear definition of a difficult pelvis that affects the surgical operation of rectal cancer. Few related research reports exist in the literature, and views on this aspect are not the same between countries. Therefore, it is particularly important to predict the difficulty of rectal cancer surgery in a certain way before surgery and to select the surgical method most suitable for each case during the treatment of rectal cancer.
“…3 ) [ 13 , 23 , 25 , 26 ] (l) Angle T4 The angle between the upper and lower borders of the pubic symphysis with the lower border of the tumor as the vertex (Fig. 4 ) [ 31 ] (m) Angle A5 The angle between the line connecting the upper and lower borders of the pubic symphysis and the line connecting the midpoint of the upper border of the pubic symphysis to the sacral promontory (Fig. 1 ) [ 16 ] Fig.…”
Due to the fixed bony structure of the pelvis, the pelvic operation space is limited, complicating the surgical operation of rectal cancer, especially middle and low rectal cancer. The closer the tumor is to the anal verge, the smaller the operative field and operating space, the longer the operative time, and the greater the incidence of intraoperative side injuries and postoperative complications. To date, there is still no clear definition of a difficult pelvis that affects the surgical operation of rectal cancer. Few related research reports exist in the literature, and views on this aspect are not the same between countries. Therefore, it is particularly important to predict the difficulty of rectal cancer surgery in a certain way before surgery and to select the surgical method most suitable for each case during the treatment of rectal cancer.
“…Application of the intestine diversion tube with a double-balloon without ileostomy in low rectal cancer laparoscopic techniques, the improvement of surgical instruments, and a rise in the technical level of surgeons have enhanced the rate of anus reservation for low rectal cancer significantly (3,4). However, the incidence of anastomotic leakage after rectal cancer is high, and leads to pelvic infection, sepsis, and even death in serious cases.…”
Background: Ileostomy is often used in low rectal cancer to protect the anastomosis and reduce the incidence of anastomotic leakage. However, the closure of the stoma causes physical and psychological damage to patients. An intestine diversion tube with a double-balloon was designed to remove the need for ileostomy and a secondary surgery, and we sought to verify its effectiveness and safety.Methods: An intestine diversion tube with a double-balloon was designed, and the experiment was performed in 5 groups of experiment pigs by the same group of physicians. The tube was placed into the ileum through the cecum during surgery. All the animals were anatomized after being anesthetized on the 14th day postoperatively to check the anastomosis and abdominal cavity. The postoperative complications included anastomotic leakage, abdominal or pelvic infection, anastomotic stenosis, postoperative bleeding, intestinal obstruction, reoperation, electrolyte disorder, drainage tube blockage, and drainage tube fall off.Results: No serious postoperative complications occurred in the 5 animal groups. The average daily drainage tube volume was 188.6 mL, the average drainage tube removal time was 13.4 days, and the average first defecation time was 2.6 days. Postoperative drainage was smooth, and no anastomotic leakage, other complications, or animal deaths occurred.
Conclusions:The use of the intestine diversion tube with a double-balloon was feasible in animal experiments and was safe and effective. The procedure is simple, and suitable for popularization and application in the clinic.
“…Because of the insidious incidence and inapparent early clinical symptoms of rectal cancer, about 75% of the clinically diagnosed patients in China have been in the middle and late stage, some of them even lose the opportunity of surgery [ 6 , 7 ]. Among them, low rectal cancer (the tumor distal location ≤ 7 cm from anal verge) accounted for most cases with poor quality of life because of the closer distance from the anus and lower anus preservation rate [ 8 , 9 ].…”
Background
Long course radiotherapy plus neoadjuvant chemotherapy followed by resection (total mesorectal excision, TME) has accepted widespread recognized in the treatment of locally advanced rectal cancer (LARC). Tislelizumab, an anti-PD1 humanized IgG4 monoclonal antibody, has been demonstrated with clinical activity and is approved for treating recurrent/refractory classical Hodgkin lymphoma and locally advanced/metastatic urothelial carcinoma in China. However, the safety and efficacy of long course (neoadjuvant chemoradiotherapy, NCRT) plus tislelizumab followed by TME for LARC is still uncertain.
Methods
This NCRT-PD1-LARC trial will be a prospective, multicenter and phase II clinical trial designed to evaluate the safety and efficacy of LARC patients treated with long course NCRT plus tislelizumab followed by TME. This trial will consecutively enroll 50 stage II/III LARC patients (cT3N0M0 and cT1-3N1-2M0) with the tumor distal location ≤ 7 cm from anal verge at 7 centers in China. The enrolled patients will receive long course radiotherapy (50 Gy/25 f, 2 Gy/f, 5 days/week) and three 21-day cycles capecitabine (1000 mg/m2, bid, po, day1-14) plus three 21-day cycles tislelizumab (200 mg, iv.gtt, day8), followed by TME 6–8 weeks after the end of radiotherapy. The primary efficacy endpoint will be the pathological complete response (pCR) rate, which is defined as absence of viable tumor cells in the primary tumor and lymph nodes.
Discussion
To our knowledge, this trial is the first multicenter clinical trial in China to assess the safety and efficacy of NCRT plus anti-PD1 therapy followed by TME to treat patients with LARC. NCRT followed by TME was recognized as the most recommended treatment against LARC while could not be completely satisfied in clinic. This study expects to provide a solid basis and encouraging outcomes for this promising combination of radiotherapy, chemotherapy and immunotherapy in LARC.
Trial registration
Name of the registry: ClinicalTrials.gov. Trial
registration number: NCT04911517. Date of registration: 23 May 2021. URL of
trial registry record: https://www.clinicaltrials.gov/ct2/show/NCT04911517?id=BFH-NCRTPD&draw=2&rank=1.
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