Per-oral endoscopic salpingo-oophorectomy (POESY) in humans: a prospective clinical feasibility study.

BACKGROUND AND AIMS: Natural orifice translumenal endoscopic surgery (NOTES) procedure describes a surgical approach using natural orifices. We describe a prospective non-comparative clinical study on transgastric salpingo-oophorectomy in humans. METHODS: Patients with indication for salpingo-oophorectomy were offered the transgastric approach. This paper presents the data of the first 6 patients, in whom the procedure was performed. After gastroscopic incision in the anterior corpus wall we advanced the flexible gastroscope into the abdominal cavity. With the help of a transvaginally introduced 10 mm trocar and, if the uterus was present, an intrauterine manipulator, the salpingo-oophorectomy was performed. The colpotomy was dilated and the specimens were extracted in a bag. The gastrotomy was closed with an over-the-scope-clip and the colpotomy with a running suture. RESULTS: The planned salpingo-oophorectomy was performed successfully in all patients. All patients recovered quickly and were discharged between the third and fifth day. In one patient a gastric bleeding was seen on the first postoperative day. The bleeding was clipped gastroscopically, all other follow ups were uneventful. CONCLUSION: Our study demonstrates the feasibility of the transgastric access to the pelvis. The gastroscope provided excellent optical control and good tissue preparation. Therefore, we conclude that pure NOTES procedures using the transgastric access to the adnexa are feasible. An increasing role of transgastric procedures for diseases in the pelvic region can be expected in particular if new endoscopic platforms with better means of instrumentation and tissue management become available.

Analysis of the First 217 Appendectomies of the German NOTES Registry.

OBJECTIVE: To analyze the feasibility and safety of Natural Orifice Transluminal Endoscopic Surgery (NOTES) appendectomy, and to analyze separately the transvaginal appendectomy (TVAE) and the transgastric appendectomy (TGAE) procedures. BACKGROUND: Laparoscopic appendectomy has rare but relevant complications, namely incisional hernias and neuralgia at the trocar sites, which can potentially be avoided by the NOTES techniques. METHODS: The first 217 data sets of the largest NOTES registry worldwide-the German NOTES registry-were analyzed with respect to demographic data, procedural data, and short-term outcomes. Furthermore, TVAEs were compared with TGAEs. RESULTS: Almost all procedures were performed in hybrid technique (median of percutaneous trocars: 1). Median age (TVAE: 30.5 yrs vs TGAE: 25 yrs; P < 0.017), body mass index (TVAE: 22.8 kg/m vs TGAE: 24.1 kg/m; P < 0.016), and American Society of Anesthesiologists (ASA) classification (I/II/III; TVAE: 57.1%/41.8%/1.0% vs TGAE: 27.8%/69.4%/2.8%; P < 0.003) significantly differed between both access techniques. Whereas the median number of percutaneous trocars (TVAE: 1 vs TGAE: 1; P < 0.450), the need of additional trocars (TVAE: 6.6% vs TGAE: 13.9%; P < 0.156), the intra, and also postoperative rate of complications (TVAE: 0%/5.5% vs TGAE: 0%/11.1%; P < 1.000/0.258), and the median postoperative hospital stay (TVAE: 3 d vs TGAE: 3 d; P < 0.152) were comparable; the median procedural time (TVAE: 35 minutes vs TGAE: 96 minutes; P < 0.001) and conversion to laparotomy rate (TVAE: 0% vs TGAE: 5.6%; P < 0.023) were significantly less after TVAE. CONCLUSIONS: The evaluation of the largest patient collective so far indicates that hybrid NOTES appendectomy is a safe procedure, with advantages for the transvaginal technique with respect to procedural time and conversion rate.

Submucosal injection with waterjet improves endoscopic mucosal resection of colorectal adenoma - a randomised controlled clinical trial.

PURPOSE: Endoscopic mucosal resection (EMR) of colorectal adenomas leads to a reduced incidence of, and mortality from, colorectal carcinoma. Large adenomas are especially difficult to resect. Submucosal injection is a key part of EMR, as it allows for complete resection and decreased complications. We previously demonstrated in both animal models and a clinical trial that a focussed fluid beam applied to the mucosa creates selective fluid cushions in the submucosa selective tissue elevation by pressure (STEP). In this study, we examined the potential of this new technique compared to the standard inject and cut technique. METHODS: This was a monocentric prospective two armed randomised controlled clinical trial comparing the STEP technique to the standard needle injection. We included patients with Yamada I and II adenomas ≥12 mm. RESULTS: One hundred fifty-five patients were treated in the trial. With the STEP technique there was a significantly higher rate of en-bloc resection, whereas piecemeal resection was more common in the standard arm. The odds ratio of piecemeal resection was 2.422 with a 95% confidence interval of 1.163-5.045 (p value .0195). There was no significant difference in resection time between the two techniques, while there was a significant difference in resections speed for the STEP technique. There was also no difference in complication rates. CONCLUSIONS: This study demonstrated that the new STEP technique leads to a higher rate of en-bloc resections than the standard injection technique in endoscopic mucosa resection of colorectal adenomas. The STEP technique can play an important role in the future of EMR.

Natural orifice transluminal endoscopic surgery in humans: feasibility and safety of transgastric closure using the OTSC system.

BACKGROUND: NOTES is a technique in which an operation is performed within the body without a skin incision by using a natural body orifice to provide access. The principal challenge of transgastric NOTES procedures is still the feasibility and safety of access closure. Currently, there are very limited data regarding the closure of transgastric NOTES in humans, and the standard method and device for closure has not been defined. Herein, we evaluate the feasibility and safety of gastric closure after NOTES procedures in humans with the over-the-scope clip (OTSC). METHODS: Review of collected data of patients underwent transgastric NOTES in prospective clinical studies between April 2010 and March 2014 focused on the gastric closure with the OTSC. RESULTS: A total of 43 patients underwent transgastric NOTES: 36 patients with an acute appendicitis, six patients with a prophylactic bilateral salpingo-oophorectomy, and one patient with uterus myomatosus. In all 43 cases, the incision of the gastric wall and the endoscopic access to the abdominal cavity succeeded without any difficulty. After performing transgastric procedures, it was possible to close the access by OTSC in all cases. There were all in all three adverse events: one major (Clavien-Dindo Grade III) and two minor (Clavien-Dindo Grades I and II). CONCLUSION: Even if we could show for the first time in more than 40 consecutive patients that there is a safe approach for closing the transgastric access, it is absolutely necessary that further investigation in clinical settings has to be done to establish clear indications and guidelines for the use of transgastric NOTES.

Endoscopic application of polysaccharide powder for hemostasis in anticoagulated pigs (with video).

BACKGROUND: Acute GI bleeding remains a clinical problem of daily importance. Increasing numbers of patients with compromised coagulation challenge the established methods of endoscopic hemostasis. Therefore, new powders for the treatment of GI bleeding have been developed. OBJECTIVE: To clarify the efficacy of a newly available anticoagulant powder in stopping hemorrhage. DESIGN: A randomized prospective comparative study regarding the potential of an endoscopically applicable polysaccharide powder in pigs receiving antithrombotic medication. SETTING: A professional veterinary animal laboratory. PATIENTS: Twenty-two pigs were anticoagulated with heparin (n = 8), aspirin (n = 8), or no antithrombotic medication (n = 6), in a randomized order. INTERVENTIONS: A bleeding ulcer with continuous bleeding (Forrest I b) was established in the stomach. Endoscopic hemostasis was performed using the powder. MAIN OUTCOME MEASUREMENTS: Time to hemostasis and the amount of powder used were recorded. Follow-up occurred for 3 days, final hemoglobin measurement, followed by autopsy with control for post-interventional bleeding. RESULTS: Endoscopic hemostasis was successful in all cases. Post-interventional bleeding was not recorded. LIMITATIONS: Animal study, artificial superficial bleeding source. CONCLUSION: Polysaccharide powder is able to stop active bleeding from Forrest I b lesions in pigs receiving antithrombotic therapy.

Pure natural orifice transluminal endoscopic surgery (NOTES) involving peroral endoscopic salpingo-oophorectomy (POESY).

OBJECTIVE: Natural orifice transluminal endoscopic surgery (NOTES) is a surgical approach that uses natural orifices to gain access to areas of the body. In the present article, we describe the first transgastric pure NOTES salpingo-oophorectomy, which we call peroral endoscopic salpingo-oophorectomy (POESY). METHODS: A woman with BRCA1 mutation presented for prophylactic bilateral salpingo-oophorectomy. We offered her the transgastric approach, having performed more than 25 transgastric appendectomies. After gastroscopic incision in the corpus wall, we advanced the gastroscope into the abdominal cavity. Salpingo-oophorectomy was performed with the help of an intrauterine manipulator and a transvaginally introduced 5-mm trocar. The posterior colpotomy was dilated and the specimens were extracted. The gastrotomy was closed with an over-the-scope clip, and the colpotomy with a running suture. RESULTS: The gastroscope provided excellent optical control and good tissue preparation. Prophylactic bilateral salpingo-oophorectomy was performed successfully via POESY. The patient recovered quickly and was discharged on the third day, with an uneventful follow-up. CONCLUSION: The present case demonstrates the feasibility of transgastric access. The gastroscope provided excellent optical control and good tissue preparation. Therefore, we expect an increasing role of transgastric procedures for diseases in the pelvic region, particularly if new endoscopic platforms with better means of instrumentation and tissue management become available.

New methods of magnet-based instrumentation for NOTES.

INTRODUCTION: Laparoscopic surgery has displaced open surgery as the standard of care for many clinical conditions. NOTES has been described as the next surgical frontier with the objective of incision-free abdominal surgery. The principal challenge of NOTES procedures is the loss of triangulation and instrument rigidity, which is one of the fundamental concepts of laparoscopic surgery. To overcome these problems necessitates the development of new instrumentation. material and methods: We aimed to assess the use of a very simple combination of internal and external magnets that might allow the vigorous multiaxial traction/counter-traction required in NOTES procedures. The magnet retraction system consisted of an external magnetic assembly and either small internal magnets attached by endoscopic clips to the designated tissue (magnet-clip-approach) or an endoscopic grasping forceps in a magnetic deflector roll (magnet-trocar-approach). RESULTS: We compared both methods regarding precision, time and efficacy by performing transgastric partial uterus resections with better results for the magnet-trocar-approach. DISCUSSION: This proof-of-principle animal study showed that the combination of external and internal magnets generates sufficient coupling forces at clinically relevant abdominal wall thicknesses, making them suitable for use and evaluation in NOTES procedures, and provides the vigorous multiaxial traction/counter-traction required by the lack of additional abdominal trocars.

Differences in the endoscopic closure of colonic perforation due to diagnostic or therapeutic colonoscopy.

OBJECTIVE: To describe the experience of a single center regarding the feasibility of endoscopic closure of iatrogenic colonic perforations and to elucidate differences between the efficacy of endoscopic clip closure due to diagnostic or therapeutic colonoscopy. MATERIAL AND METHODS: A retrospective institutional computer-based search of records of colonoscopic perforation occurring between January 2004 and December 2011 was undertaken. Data on patients undergoing colonoscopy were entered into a clinical database. To further improve the detection of all cases of colon perforations, the authors also searched their separate surgical database for every patient with a colon perforation treated or operated on in the surgery department. Statistical significance was tested using either Fortran-Subroutine Fytest, chi-square testing or t-test. RESULTS: Over 8 years, 22,924 patients underwent colonoscopy, of which 105 consecutive patients suffered iatrogenic perforation. Clip application was possible in 62 patients (81.58%) after perforation due to a therapeutic colonoscopy, whereas clip application was only possible in 9 patients (31.03%) after perforation due to a diagnostic colonoscopy. 4 out of 9 patients (44.44%) in the diagnostic group compared with 7 out of 62 patients (11.29%) after clipping a perforation during a therapeutic colonoscopy were sent to surgery. CONCLUSIONS: The authors' data indicate significant differences in the potential for and success of endoscopic closure of iatrogenic perforations occurring during diagnostic or therapeutic colonoscopy. The frequency of surgery was significantly greater after clipping a perforation during a diagnostic colonoscopy.

The EURO-NOTES clinical registry for natural orifice transluminal endoscopic surgery: a 2-year activity report.

BACKGROUND: The EURO-NOTES Clinical Registry (ECR) was established as a European database to allow the monitoring and safe introduction of Natural Orifice Transluminal Endoscopic Surgery (NOTES). The aim of this study was to analyze different techniques applied and relative results during the first 2 years of the ECR. METHODS: The ECR was designed as a voluntary database with online access. All members of the European Society for Gastrointestinal Endoscopy and the European Association for Endoscopic Surgery were requested to participate in the registry. Demographic and therapy data as well as data on the postoperative course are recorded in the ECR in an anonymous way. RESULTS: A total of 533 patients who underwent NOTES procedures were included in the study. Four different hybrid techniques for 435 cholecystectomies were described, registering postoperative complications in 2.8% of patients, addition of a single trocar in 5.3%, and conversions to laparoscopy in 0.5%. Both flexible endoscopic and rigid laparoscopic cholecystectomy techniques proved to be safe and effective with minor differences. There was a shorter operative time in the rigid laparoscopic group. Thirty-three appendectomies were reported by transgastric and transvaginal techniques, with transvaginal techniques scoring shorter operative time and hospital stay, but with a frequent need to add more trocars. Overall complications occurred in 14.7% of patients but they did not differ significantly among the different techniques. One transvaginal and 31 transanal sigmoidectomies were included for prolapse and diverticulitis, with four postoperative complications (12.5%), but none needing further treatment. Twenty peroral esophageal myotomies were included with three postoperative complications (15.0%), but none needing further treatment. CONCLUSIONS: Five years since the introduction of NOTES into clinical practice, hybrid techniques have gained considerable clinical application. Several NOTES hybrid cholecystectomy and appendectomy techniques are practicable and safe alternatives to laparoscopic procedures. Also, sigmoidectomies and peroral esophageal myotomies were described, proving feasibility and safety. Nevertheless, the real benefit of NOTES for patients still needs to be assessed.

Experimental endoscopic submucosal dissection training in a porcine model: learning experience of skilled Western endoscopists.

BACKGROUND: Endoscopic submucosal dissection (ESD) demands a new level of endoscopic skill in Europe. A 2-day workshop was set up for trainees to carry out five ESD each in order to obtain the skill level required to perform ESD in the stomach or rectum. This study describes: (i) the workshop setup; (ii) the participant's performance; and (iii) the training effect on post-workshop clinical ESD performance. METHODS: Eighteen very experienced European endoscopists participated in four half-day (4.5 h) training sessions, with everybody rotating daily through six separate training stations (two each with dual, hook, or hybrid knives) with expert tutors. One anesthetized piglet was used per station and session. After 1 year, the clinical ESD performance was surveyed to estimate the training effect of the workshop. RESULTS: Overall, 74 ESD were performed, that is, 4.1 ESD per participant. On average ESD lasted 57 min for 6 cm(2) specimens. We detected a 22% rate of perforation (16 of 74 ESD with perforations), mostly attributable to participants with less experience in ESD. Those who started clinical ESD within 1 year after the workshop performed 144 clinical ESD (median 8 [0-20] per trainee) mostly in the stomach (40%) and large bowel (46%) with an acceptable rate of perforation (9.7%) and surgical repair (3.5%) without mortality or persistent morbidity. CONCLUSION: Intense skill training for ESD is needed to reduce the risk of perforation, as demonstrated by the results of this workshop. We show that experimental ESD training, however, enables skilled European endoscopists to perform ESD in standard locations with moderate risk of perforation during the clinical learning curve.

Topoisomerase I expression correlates to response to neoadjuvant irinotecan-based chemoradiation in rectal cancer.

Biomarkers may help predict the efficacy of neoadjuvant chemoradiation in patients with rectal cancer. We hypothesized that the expression of topoisomerase I (Topo I) and thymidylate synthase (TS) may help predict the treatment response in patients undergoing irinotecan and capecitabine-based chemoradiation. Patients with rectal cancer (cT3/4Nx or Tx/N+) received neoadjuvant chemoradiotherapy within clinical studies with irinotecan and capecitabine. Samples of normal and tumour tissues were collected before the start of the treatment and during surgical resection. Topo I and TS were measured using real-time PCR. The results of gene expression levels were compared between responders (defined as ypT0-2 ypN0) and nonresponders (ypT3-4 or ypN1/2). A total of 38 patients were analysed, 18 of them were responders. The biopsies of the untreated tumour tissue of responding patients showed a significant higher expression of Topo I compared with nonresponding patients (P = 0.015). Normal tissue did not show this difference (P = 0.126). During chemoradiation, the Topo I expression in tumour tissue of responders decreased significantly. TS did not show any differences between responders and nonresponders before treatment, but a significant decrease in the tumour tissue of responders was noted at the end of the treatment. Our data suggest that Topo I expression in rectal tumour mucosa might serve as a predictor of response to the neoadjuvant irinotecan-based chemoradiation, and hence might be a factor contributing to the development of individualized treatment.

Combination of water-jet dissection and needle-knife as a hybrid knife simplifies endoscopic submucosal dissection.

BACKGROUND: The safety and efficacy of endoscopic submucosal dissection (ESD) is very dependent on an effective injection beneath the submucosal lamina and on a controlled cutting technique. After our study group demonstrated the efficacy of the HydroJet in needleless submucosal injections under various physical conditions to create a submucosal fluid cushion (Selective tissue elevation by pressure = STEP technique), the next step was to develop a new instrument to combine the capabilities of an IT-Knife with a high-pressure water-jet in a single instrument. In this experimental study, we compared this new instrument with a standard ESD technique. METHODS: Twelve gastric ESD were performed in six pigs under endotracheal anesthesia. Square areas measuring 4-cm x 4-cm were marked out on the anterior and posterior wall in the corpus-antrum transition region. The HybridKnife was used as an standard needle knife with insulated tip (i.e., the submucosal injection was performed with an injection needle and only the radiofrequency (RF) part of the HybridKnife was used for cutting (conventional technique)) or the HybridKnife was used in all the individual stages of the ESD, making use of the HybridKnife's combined functions (HybridKnife technique). The size of the resected specimens, the operating time, the frequency with which instruments were changed, the number of bleeding episodes, and the number of injuries to the gastric wall together with the subjective overall assessment of the intervention by the operating physician were recorded. RESULTS: The resected specimens were the same size, with average sizes of 16.96 cm(2) and 15.85 cm(2) resp (p = 0.8125). Bleeding episodes have been less frequent in the HybridKnife group (2.83 vs. 3.5; p = 0.5625). The standard knife caused more injuries to the lamina muscularis propria (0.17 vs. 1.33; p = 0.0313). The operating times had a tendency to be shorter with the HybridKnife technique (47.18 vs. 58.32 minute; p = 0.0313). DISCUSSION: The combination of a needle-knife with high-pressure water-jet dissection improved the results of endoscopic submucosal dissection in this experimental setting. Because the frequency of complications is still high, further improvements to the instrument are necessary.

Preoperative staging of rectal tumors: comparison of endorectal ultrasound, hydro-CT, and high-resolution endorectal MRI.

AIM: The aim of this study was to compare transrectal ultra-sound (TRUS), hydro-computed tomography (hydro-CT), and endorectal magnetic resonance imaging (MRI) in the preoperative staging of rectal cancer. PATIENTS AND METHODS: 23 patients with rectal adenocarcinoma underwent TRUS, hydro-CT, and MRI (1 Tesla) with endorectal coil. The results were correlated with the histopathological findings based on the TNM classification. RESULTS: T staging with TRUS, hydro-CT, and endorectal MRI correlated with the histopa-thological findings in 83% of patients (19/23). Tumors were overestimated by TRUS in 2/23 patients, by CT in 3/23, and by MRI in 3/23 patients. Tumor size was underestimated by TRUS in 2 patients, by CT and MRI in 1 case each. Local lymphatic node involvement was correctly diagnosed with CT and MRI in 87% and 83%, respectively. Using TRUS, false-negative results in the staging of lymph node involvement were seen in 3/23 patients, whereas 1 patient was over-staged. Using hydro-CT as well as endorectal MRI, overstaging of the local lymph nodes took place in 2/23 patients. CONCLUSION: All methods are limited because peritumoral inflammation cannot be precisely distinguished from infiltration by the tumor. Correct lymph node staging is hampered in advanced disease using TRUS. In these patients, further cross-sectional imaging may be required.

The Merendino procedure following preoperative imatinib mesylate for locally advanced gastrointestinal stromal tumor of the esophagogastric junction.

BACKGROUND: Gastrointestinal stromal tumors (GIST) of the esophagogastric junction might pose a major problem to surgical resection. If locally advanced, extended or multivisceral resection with relevant procedural-specific morbidity and mortality is often necessary. CASE PRESENTATION: We report a case of a patient with a locally advanced GIST of the esophagogastric junction who was treated by transhiatal resection of the lower esophagus and gastric cardia with reconstruction by interposition of segment of the jejunum (Merendino procedure). Prior to resection, downsizing of the tumor had successfully been achieved by treatment with imatinib mesylate for six months. Histological proof of GIST by immunohistochemical expression of c-KIT and/or PDGF alpha Receptor is crucial to allow embarking on this treatment strategy. CONCLUSION: A multimodal approach for an advanced GIST of the esophagogastric junction with preoperative administration of imatinib mesylate could avoid extended resection. The Merendino procedure might be considered as the reconstruction method of choice after resection of GIST at this location.

Endoclipping of iatrogenic colonic perforation to avoid surgery.

BACKGROUND: Colonoscopy is an established tool for the diagnosis and management of colonic and rectal pathology. Even though colonic perforation is rare after colonoscopy, it is a serious and typical complication. The definitive management remains controversial. Both operative and nonoperative techniques have been described in the literature, though the standard treatment for these patients is still an operative repair of the perforation site. Recently, endoscopic clip application was recommended, particularly for iatrogenic perforations, but less is known about the effectiveness of endoluminal repair of colonic perforations with clips. METHODS: In this series, 7589 colonoscopies were performed over a 34-month period in a tertiary-level referral center. Three perforations occurred during 5413 diagnostic colonoscopies. Therapeutic colonoscopy was under taken in 2176 patients, resulting in a total of 27 perforations. Out of 30 patients with colonic perforation, five patients underwent operative management and 25 patients were subsequently treated nonoperatively. RESULTS: In 27 patients, endoscopic application of inert metallic clips was used for closure of iatrogenic perforation. Twenty-five of these patients were treated non-operatively, while two patients underwent surgery. The mean postoperative length of hospitalization for patients was 12.2 days, compared to 3.5 days for patients treated conservatively. CONCLUSIONS: Endoluminal repair of colonic perforations with clips and further conservative treatment seems to provide a tool that avoids the major additional trauma associated with laparotomy or laparoscopy and minimizes the length of hospitalization.

Fatal coil migration into the stomach 10 years after endovascular celiac aneurysm repair.

Celiac trunk aneurysms are rare and can be treated with coil embolization. Migration of the coil with erosion of the arterial wall and further perforation to an extravascular structure, although infrequent, can occur. The authors describe a lethal aortogastric fistula in a patient who had undergone embolization of a celiac trunk aneurysm with tungsten coils and alcohol prolamine solution 10 years earlier. Gastroscopy, performed due to acute hematemesis, showed the coil placed 10 years previously inside the stomach without active bleeding. Two days later, the patient died of a recurrent gastrointestinal bleeding. Autopsy showed abscess formation at the celiac trunk resulting in an aortogastric fistula. The authors discuss the possible cause of this remote complication of the embolotherapy.

The influence of early supplementation of parenteral nutrition on quality of life and body composition in patients with advanced cancer.

BACKGROUND: According to current evidence, most organizations, including the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.), do not recommend the routine use of artificial nutrition for patients with cancer. Despite the recommendation for parenteral nutrition (PN), data for early PN supplementation (PNS) in patients with an advanced malignancy are extremely limited, especially in terms of the affects on nutrition outcomes, body composition, and quality of life (QOL), as well as effects on oncologic outcomes. The aim of the study was to evaluate the effect of PNS on body composition and the quality of life in patients with advanced malignancies. METHODS: One hundred fifty-two consecutive patients with advanced cancer were prospectively randomized to either use of oral enteral nutrition supplement (PN-) or use of oral enteral nutrition supplement plus supplemental PN (PN+). Body weight, body mass index (BMI), and caloric intake were assessed, and hemoglobin (g/dL) and serum albumin (g/L) were measured. Body composition was assessed by body impedance analysis (BIA), and QOL was evaluated by European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire every 6 weeks. RESULTS: No significant differences were evident at baseline between the 2 groups for age, gender, medical diagnosis, weight, BMI, or QOL. A statistically significant difference in mean BMI was observed by week 48 for the PN+ group (PN+ = 21.9, PN-= 20.5, p = .0149), by week 6 in mean body cell mass (PN+ = 55%, PN-= 50,1%, p < .001), mean albumin (PN+ = 40.2 g/L, PN-= 36.2 g/L, p = .015), mean QOL (PN+ = 55.7, PN-= 50.9, p = .035). The cumulative survival rate was significantly greater in the PN+ group (p < .0001). CONCLUSIONS: According to the positive effect of supplemental PN on survival, body composition, and QOL, additional controlled studies must be conducted to confirm these findings.

Retraction: The Influence of Early Supplementation of Parenteral Nutrition on Quality of Life and Body Composition in Patients With Advanced Cancer.

The authors of the above article have requested its withdrawal, notifying the Journal that the clinical trials described in the article were not conducted as written in the article. The Editor-in-Chief, the American Society for Parenteral and Enteral Nutrition, and the Publisher have determined to retract the article.