Introduction

Severe bleeding from radiation proctopathy (RP) affects around 6% of people treated with radiotherapy for pelvic cancer¹. Purastat, a haemostatic agent licensed to treat bleeding from blood vessels in the gut, has been shown to have haemostatic benefit during surgery and endoscopic procedures^2-6. Early case series data for patients with RP have shown improvements in rectal bleeding and endoscopic appearance with no adverse effects⁷, however the effects compared to treatment as usual (TAU, sucralfate enemas) have not previously been studied.

Aims & Methods

In this first clinical trial of Purastat for RP, we investigated the feasibility, acceptability and safety outcomes in comparison to standard treatment (ISRCTN NCT04918758).
Adults with significant bleeding from endoscopically confirmed RP recruited from 3 centres (Manchester University NHS Foundation Trust, Royal Liverpool University Hospital, St Mark’s Hospital) were randomised to Purastat (5mls at baseline, week 4 and week 8) or TAU (sucralfate enemas 2g BD for 8 weeks starting at baseline visit). Significant bleeding was defined as bleeding on an at least weekly basis. Patients with other causes of rectal bleeding, or who had previously been treated with sucralfate enemas or Purastat, were excluded.
Clinical and endoscopic assessments were made at baseline, week 4, week 8 and week 20. Episodes of rectal bleeding were assessed using a patient reported diary 7 days before and after each assessment. Endoscopic grade was recorded at each assessment using the Zinicola score, Rectal Telangectasia Density Score (RTDS) and Vienna Rectoscopy Score. Participant satisfaction was assessed using Client Satisfaction Questionnaire-8 (CSQ8).

Results

143 patients were screened over 25 months. 26 patients were consented (18%) and 25 started the study. 13 were randomised to the Purastat group. 20 participants completed the study. 5 participants (20%) withdrew (4 TAU, 1 Purastat).
Baseline demographic and clinical outcome data are shown in Table 1.
There were no adverse events relating to Purastat or TAU.
There was an improvement in rectal bleeding episodes, endoscopic grade and number of participants with anaemia in both groups. There is a possible trend towards better outcomes in the Purastat group, but as this is a small feasibility study it is not powered to detected differences between groups.
All participants reported being “very satisfied” or “mostly satisfied” overall (CSQ8).

Table 1: Baseline demographic and clinical outcome data

Conclusion

This study shows that the study process and intervention is safe and acceptable. Clinical and endoscopic improvement was seen in both groups. A definitive national, multicentred RCT is required to test the clinical and cost effectiveness of Purastat compared with TAU.

References

1. Gami B, Harrington K, Blake P, et al. How patients manage gastrointestinal symptoms after pelvic radiotherapy. Alimentary Pharmacology & Therapeutics. 2003;18(10):987-994.
2. Masuhara H, Fujii T, Watanabe Y, Koyama N, Tokuhiro K. Novel Infectious Agent-Free Hemostatic Material (TDM-621) in Cardiovascular Surgery. Annals of Thoracic and Cardiovascular Surgery. 2012;18(5):444-451.
3. Ellis-Behnke RG, Liang Y-X, Tay DKC, et al. Nano hemostat solution: immediate hemostasis at the nanoscale. Nanomedicine: Nanotechnology, Biology and Medicine. 2006;2(4):207-215.
4. Uraoka T, Ochiai Y, Fujimoto A, et al. A novel fully synthetic and self-assembled peptide solution for endoscopic submucosal dissection-induced ulcer in the stomach. Gastrointestinal Endoscopy. 2016;83(6):1259-1264.
5. Heller M, Wei C. Self-assembly peptide prevents blood loss. Nanomedicine: Nanotechnology, Biology and Medicine. 2006;2(4):216.
6. Luo Z, Wang S, Zhang S. Fabrication of self-assembling d-form peptide nanofiber scaffold d-EAK16 for rapid hemostasis. Biomaterials. 2011;32(8):2013-2020.
7. White K, Henson C. Endoscopically-delivered Purastat for the treatment of severe haemorrhagic radiation proctopathy: a case series. GUT. 2019;68 (Suppl 2):A195-A196.

Disclosure

Grants received from NIHR and World Cancer Research Fund.
Support received from 3D Matrix.

Introduction

Endoscopic submucosal dissection (ESD) is a highly effective and safe technique for the resection of superficial colorectal neoplasms, but it can still be technically challenging for lesions in contact with or invading the appendiceal orifice. Until recently, appendicular lesions were considered unresectable or difficult to resect by endoscopy because of the high risk of incomplete resection, perforation or acute appendicitis. Small studies have reported ESD feasibility and efficacy in this particular context, including for lesions deeply invading the appendix. However, strong data about these more complex resections is lacking and the best management strategy for this kind of lesion remains a matter of debate, with upfront surgery still being the first-choice treatment in most western countries.

Aims & Methods

With the present study, we aimed to assess and report the outcomes of ESD for the treatment of lesions in contact with or invading the appendiceal orifice. We prospectively collected data of ESD procedures for appendiceal neoplasia in a multicenter prospective register. En Bloc R0 resection rate was the primary outcome. Morbidity and additional surgery were also reported.

Results

A total of 112 patients were included, comprising 47 (42%) with previous appendectomy. Fifty-six lesions (50%) were type 3 according to Toyonaga classification (15 (13.4%) post-appendectomy). En-bloc and R0 resection rates were 86.6% and 80.4%, with no significant difference associated with different grades of appendiceal invasion (p=0.9 and p=0.4, respectively) or history of previous appendectomy (p=0.3 for both). Curative resection rate was 78.6%. Additional surgery was performed in 16 (14.3%) cases, with 10/16 (62.5%) corresponding to Toyonaga type 3 lesions (p=0.04). This included the treatment of 5 (4.5%) cases of delayed perforation and 1 acute appendicitis. A second case of acute appendicitis and 1 of delayed hemorrhage also observed, both treated conservatively.

Conclusion

To our knowledge, this is the largest reported series of ESDs for the treatment of appendicular lesions. Our results show that ESD is safe and effective in this context, and should thus be considered as a valuable treatment option. New traction strategies and devices should make it progressively less technically challenging and more widely accessible.

Introduction

Laser therapy is a relatively recent technique that allows the treatment of anal fistulas (FIstula-tract LAser Closure: FilaC®), and anal fissure (Laser anal fissure: LSL) with the FilaC fibre, pilonidal sinuses with the SiLaC® fibre (Sinus Pilonidalis treatment), and haemorrhoids with the Laser Hemorrhoido Plasty fibre (LHP®).

Aims & Methods

Our study aims to report the preliminary results of a prospective bicentric study including all patients treated with laser therapy in two private hospitals.​
​This prospective descriptive study includes 141 patients treated with laser therapy for proctological pathology (anal fistulas, pilonidal sinuses, anal fissures, and hemorrhoids) performed in two proctology units. The majority of these procedures were performed under spinal anesthesia. Data were collected directly from the patients using an evaluation form. We studied their clinical data and the immediate and medium-term postoperative follow-up

Results

141 patients were included. The mean age was 44 years (18-76 years). 78% were male and 22% female (sex ratio = 3.5). The anal fistula was the main indication for laser therapy, with FilaC® performed in 105 patients (74.5%), followed by SiLaC® in 16 patients (11.3%), LHP® in 7 patients (5%) and 4 cases of LSL (2.8%). 9 patients benefited from combined treatment: 5 LHP®+ LSL patients (3.5%), 2 FilaC®+ LSL patients (1.4%), 1 FilaC®+ SiLaC® patient (0.7%), and 1 FilaC®+ LHP® case (0.7%). 79 patients (73.2%) benefited from initial drainage of the fistula with a loose seton for 1 to 5 months before FilaC®, while 29 patients (26.8%) with a short direct extrasphincteric fistula benefited from laser therapy.18 patients were lost to follow-up (12,8%). 104 patients (84,5%), all pathologies combined, progressed well with 19 cases of failure (15,5%) with a follow-up time of 1 to 50 months. Fistulas healed in 74 patients (80%). There were 18 confirmed failures. 15 of these were treated surgically with 4 FilaC. Failure was diagnosed within an average of 6 months and was manifested by persistent leakage with no healing of the external orifice. There were no continence problems after the procedure. 16 patients were lost to follow-up. In patients with LHP, 2 patients (15,4%) experienced early post-operative bleeding requiring surgical suturing. All patients treated with SiLaC® had a favorable outcome. The 4 patients treated for anal fissures were satisfied with the procedure.

Conclusion

Laser proctology is a minimally invasive conservative procedure with significant postoperative pain reduction. In the literature, the success rate of this technique ranges from 65 to 80%. Our hospitals were the first in Morocco to introduce this procedure. Preliminary results from our pilot study showed satisfying healing in 84.5% of patients. However, long-term confirmation is required.

References

1- Adegbola SO, Sahnan K, Tozer P, Warusavitarne J. Emerging Data on Fistula Laser Closure (FiLaC) for the Treatment of Perianal Fistulas; Patient Selection and Outcomes. Clin Exp Gastroenterol. 2021 Dec 6;14:467-475. doi: 10.2147/CEG.S269464. PMID: 34908858; PMCID: PMC8664604.

Clinical Case Summary

Radiation proctitis is a common complication of radiotherapy and up to 80% of patients with chronic radiation proctitis experience rectal bleeding. Here we report the case of a 56-year-old man with type 3 von Willebrand disease (VWD) and high-titer VWF inhibitors who developed life-threatening rectorrhagia following prostate cancer radiotherapy, requiring urgent hospitalization and almost daily blood transfusions. Endoscopy revealed rectal angiodysplasia secondary to radiation proctitis as the bleeding source. Initial management included administration of recombinant FVIIa and tranexamic acid, paired with endoscopic hydrogel application and argon plasma coagulation (APC). Despite this, bleeding persisted with formation of rectal ulcers, prompting administration of prothrombin complex concentrate, extended half-life recombinant FVIII, plasma-derived VWF/FVIII concentrate, factor XIII, fibrinogen, octreotide, and bevacizumab. All interventions were ineffective and thus, after four weeks, off-label emicizumab in combination with rFVIIa was initiated, resulting in temporary improvement and subsequent discharge.
Four days later, the patient developed rectorrhagia and hemorrhagic shock. Repeated APCs and tamponade were unsuccessful, prompting a bipolar sigmoidostomy placement. Still, bleeding persisted, warranting an innovative and unconventional approach which included endoscopic application of autologous platelet-rich fibrin (PRF) and regular platelet transfusions despite normal platelet counts. Only after PRF applications were started hemostasis was gradually achieved. The patient continued emicizumab prophylaxis with biweekly outpatient PRF applications. At 10-month follow-up, he remained free of anemia and recurrence of gastrointestinal bleeding.
This case demonstrates successful management of refractory bleeding in inhibitor-complicated type 3 VWD using a combination of emicizumab and local PRF application when conventional approaches failed.

References

Figure 1. Endoscopic view of a large rectal ulceration with active bleeding, adherent clots, and visible blood vessels.
Figure 2. Endoscopic view of a healing rectal ulceration covered with fibrin.

Introduction

There are two approaches for neoadjuvant treatment in locally advanced rectal cancer: conventional radiotherapy (RT) with concomitant chemotherapy and hypofractionated RT. In the RAPIDO study, preoperative hypofractionated RT versus conventional chemo-radiotherapy was proven to be equally effective. In our country and in our center (approximately 90%) previously, the standard treatment was conventional RT, however due to the COVID 19 pandemic in 2020, an increase in the use of hypofractionated RT was observed, this because it was a more accessible therapy for patients due to visits. In our country, the results of hypofractionation therapy compared to a conventional one have not been explored, therefore we decided to compare the outcomes between these modalities.

Aims & Methods

To compare early radiotoxicity of conventional vs. hypofractionated RT.
Methods: Retrospective study conducted in a national reference cancer center at National Institute of Cancer (INCAN) at Mexico City, during the period of April 2020 to December 2020.

Results

We analyzed 61 patients with rectal adenocarcinoma. Locally advanced were 91.8% and metastatic 8.2%. By tumor location upper third 11.4%, middle third 16.4%, middle third 72.1%. Regarding treatment, 72.1% received hypofractionation (25Gy in 5 fractions) and 27.9% conventional (45-50.4 Gy in 25-28 fractions). Techniques used 93.4% 3DCRT, 4.9% IMRT and 1.6% VMAT. Regarding general toxicity, it was observed in 30 patients (68%) in the hypofractionated group and 11 patients (64%) in the conventional treatment group p=0.794. Type of radiotoxicity is described in table 1. We observed a greater radiation mucositis grade 3 in the hypofractionated group compared with standard therapy. The other types were similar with no statistical significance. Table 1.

Conclusion

We observed a considerable increase in the use of hypofractionation in which we did not observe proctitis and cystitis in relation to conventional treatment, however caution and special attention must be exercised in radiation mucositis. We can increase the use of hypofractionated treatment with almost similar radiotoxicities. Further prospective studies are required to confirm these findings.

References