ARTICLE IN PRESS doi:10.1510/icvts.2006.149500
Interactive CardioVascular and Thoracic Surgery 6 (2007) 247–250 www.icvts.org
Best evidence topic - Esophagus
Does pyloroplasty following esophagectomy improve early clinical outcomes? Omar A. Khana, James Mannersa, Arvind Rengarajanb, Joel Dunningb,* a Department of Cardiothoracic Surgery, Southampton General Hospital, UK Department of Cardiothoracic Surgery, James Cook University Hospital, Middlesbrough, UK
b
Received 28 November 2006; accepted 5 December 2006
Summary A best evidence topic in thoracic surgery was written according to a structured protocol. The question addressed whether pyloroplasty following elective esophagectomy improves clinical outcomes. Altogether 170 relevant papers were identified using the below-mentioned search. One meta-analysis and six randomised controlled trials from the nine that were summarised in the meta-analysis represented the best evidence to answer the question. The author, journal, date and country of publication, patient group studied, study type, relevant outcomes, results and study weaknesses were tabulated. We conclude that pyloroplasty seems to reduce the incidence of gastric outlet obstruction and speed up gastric emptying. In addition, the incidence of complications from this procedure seems low. However, other significant improvements to outcomes such as mortality, nutrition, anastomotic leakage, gastric symptoms and aspiration are yet to be established. 2007 Published by European Association for Cardio-Thoracic Surgery. All rights reserved. Keywords: Pyloroplasty; Esophagectomy; Evidence based medicine
1. Introduction
retrosternal stomach.mpx AND wpyloroplasty.mp OR gastric drainage.mp OR pyloromyotomy.mpx
A best evidence topic was constructed according to a structured protocol. This protocol is fully described in the ICVTS w1x.
5. Search outcome
2. Clinical scenario
A total of 170 papers were identified. One meta-analysis was found that summarised nine randomised controlled trials. This study, together with the best six RCTs, were selected (Table 1).
You are performing an esophagectomy for a cT2N0M0 adenocarcinoma of the gastro esophageal junction. You have just mobilised the stomach and your surgical assistant asks whether you plan to perform a pyloroplasty as he has heard it is associated with improved early postoperative recovery. You do not routinely do this but decide to check the literature after the operation. 3. Three-part question In wpatients undergoing esophagectomyx does a wpyloric drainage procedurex improve wearly or late clinical outcomesx. 4. Search strategy Medline 1966 to November 2006 using the OVID interface. wexp esophagectomyyOR esophagectomy.mp or oesophagectomy.mp OR esophagus.mp OR oesophagus.mp OR *Corresponding author. Tel.yFax: q44-780-1548122. E-mail address:
[email protected] (J. Dunning). 2007 Published by European Association for Cardio-Thoracic Surgery
6. Discussion Although esophagectomy for cancer is a well-established operation, there exists much controversy as to the optimum surgical approach. With specific reference to routine pyloroplasty, advocates of this approach argue that this intervention prevents early gastric outlet obstruction associated with pyloric denervation, and hence, reduces the risk of pulmonary aspiration. By contrast, it has been argued that pyloroplasty is unnecessary as gastric outlet obstruction is a rare occurrence following esophagectomy and that the procedure itself is associated with a number of complications. Urschel et al. w2x performed a meta-analysis in 2002, finding nine randomised controlled trials w3–11x, that included 553 patients. They found non-significant trends towards a benefit of pyloroplasty for pulmonary morbidity (odds ratio 0.69 95% CI 0.42–1.14, Ps0.15), pulmonary aspiration (odds ratio 0.25 95% CI 0.04–1.6, Ps0.14), and a significant benefit for gastric outlet obstruction (odds
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Table 1 Best evidence papers Author
Patient group
Outcome
Key results
Comments
Urschel et al., (2002), Digest Surg, Canada, w2x
Meta-analysis of RCTs on the effect of pyloric drainage on patient outcomes
Mortality drainage vs. no drainage
0.92 (95% CI 0.34–2.44) Ps0.77
Search strategy for Medline revealed only 11 citations. Used unreliable filters such as randomised controlled trial.pt to narrow the search
Meta-analysis (level 1a)
Medline and manual journal search of studies of pyloroplasty or pyloromyotomy
Anastomotic leaks
0.90 (95% CI 0.47–1.76) Ps0.77
Pulmonary morbidity
0.69 (95% CI 0.42–1.14) Ps0.15
Pyloric drainage complications
2.55 (95% CI 0.34–19.0) Ps0.36
Fatal pulmonary aspiration
0.25 (95% CI 0.04–1.6) Ps0.14
Gastric outlet obstruction
0.18 (95% CI 0.03–0.97) Ps0.046
Operative mortality
Four mortalities in control vs. three in pyloplasty group
Anastomotic leak
Five leaks in each of the two group
Pulmonary complications
23 in control group vs. 16 in the pyloroplasty group
Fatal aspiration
Two cases in control group vs. 0 in the pyloroplasty group
Early gastric outlet obstruction
13 in the control group vs. 0 in the pyloroplasty group
Operative mortality
Two mortalities in control vs. four in pyloroplasty group
Anastomotic leak
11 leaks in the control group vs. nine in pyloroplasty group
Pulmonary complications
Eight in control group vs. five in pyloroplasty group
Fatal aspiration
0 cases in control group vs. 0 in the pyloroplasty group
Early gastric outlet obstruction
Ten in the control group vs. five in the pyloroplasty group
Operative mortality
Three mortalities in control vs. one in pyloroplasty group
Fatal aspiration
Three cases in control group vs. 0 in the pyloroplasty group
Nine RCTs with 553 patients identified
Fok et al., (1991), Am J Surg, Hong Kong, w3x PRCT (level 1b)
Zieran et al., (1995), Chirurg, Germany, w7x PRCT (level 1b)
200 patients undergoing Lewis Tanner Esophagectomy: Group 1: Pyloroplasty (ns100) Group 2: Control (ns100)
107 patients undergoing subtotal esophagectomy and gastric substitution with cervical esophagogastric anastomosis Group 1: Pyloroplasty (ns52) Group 2: Control (ns55)
Mannell et al., (1990), Brit J Surg, South Africa, w5x
40 patients undergoing undergoing retrosternal gastric reconstruction of the esophagus
PRCT (level 2b)
Group 1: Pyloroplasty (ns20) Group 2: Control
90% pyloroplasties Informal ‘semiquantitative’ assessment of long-term outcomes: late gastric emptying, nutrition and obstructive foregut symptoms better in drainage groups
This was a well conducted and large scale study. Although there was a tendency to improved outcomes in patients who underwent pyloplasty, this difference was not statistically significant
Although well conducted, this study was primarily designed to assess longterm outcomes. Whilst there was a slight trend towards reduced anastomotic leak rate and pulmonary complications in the control group, the overall mortality rate in the control group was lower and the authors concluded there was no evidence to support routine pyloromyotomy
This was a small study with limited outcomes measures (no information given on the pulmonary complications or anastomotic leak rate). The small size of the study severely limits its utility
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Table 1 (Continued) Author
Patient group
Outcome
Key results
(ns20)
Early gastric outlet obstruction
Nine in the control group vs. 1 in the pyloroplasty group
Chattopadhyay et al., (1991), Aust NZ J Surg, India, w12x
24 patients undergoing esophagectomy for with cervical esophagogastrostomy
Postoperative gastric emptying
No pyloroplasty 370"25 min Pyloroplasty 16"23 min P-0.01
PRCT (level 2b)
Heineke-Mikulicz pyloroplasty. ns12
Dumping syndrome
No pyloroplasty one patient Pyloroplasty two patients
Post-prandial discomfort
No pyloroplasty one patient Pyloroplasty 0 patients
Nasogastric aspiration postoperatively
No pyloroplasty 266"187 ml Pyloroplasty 170"142 ml Ps0.13
Gastrograffin swallow one week post-op
No pyloroplasty one gross distension, two mild symptoms Pyloroplasty no problems
Gastric emptying at six months (Half time)
No pyloroplasty 40"38 min Pyloroplasty 12"9.6 min P-0.01
Food ejection time of foods
Pyloroplasty 19.6"31.0 min, Controls 32.9"37.2 min
Control group. ns12
Cheung et al., (1986), Surgery, Hong Kong, w13x
72 patients undergoing transthoracic esophagectomy
PRCT (level 2b)
Randomised to Heineke-Mikulicz pyloroplasty. ns35 Controls. ns37
Kobayashi et al., (1996), Nippon Kyobu Geka Gakkai Zasshi, Japan, w8x
67 patients with esophageal carcinoma underwent subtotal esophagectomy and reconstruction using a gastric tube
PRCT (level 2b)
34 randomised to pyloroplasty and 33 to a control group Gastric function evaluated at one and six months
Rapid Turnover protein
No differences
Prognostic Nutritional count
No differences
ratio 0.18 95% CI 0.03–0.97, Ps0.046). They also attempted to assess in a semi-quantitative fashion the results of later gastric symptoms reported by papers by assigning scores to outcomes described by the original papers. They found non-significant trends towards quicker gastric emptying, food intake, and foregut obstructive symptoms. They concluded that pyloric drainage procedures reduce the occurrence of early postoperative gastric outlet obstruction after esophagectomy with gastric reconstruction, but they have little effect on other early and late patient outcomes.
Comments
Small study Preoperative gastric emptying mean 38 min
Not translated from Japanese Faster gastric emptying shown at one month but no nutritional benefits shown at six months
The largest RCT was by Fok et al. w3x in 1991, where 200 patients undergoing Lewis-Tanner esophagectomy were randomised to pyloroplasty or control. Thirteen patients without drainage developed obstructive symptoms compared to none in the drainage group. In addition, significant benefits were shown for early and late symptoms with meals, although all other outcome measures showed only nonsignificant trends towards benefit. Zieren et al. w7x randomised 107 patients to pyloroplasty or control but found no significant differences between the
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two groups. However, the complication rates in this study were low in both groups. Mannell et al. w5x performed a 40-patient RCT looking at gastric emptying, but again, due to the low incidence of symptoms, no significant differences were seen. Chattopadhyay et al. w12x performed a small RCT to look at gastric emptying in 24 patients. Emptying was significantly delayed by more than 10 times in both groups postoperatively compared to preoperatively, but the difference was significantly better in the pyloroplasty group. There were no other differences in either group. Kobayashi et al. w8x performed a 67-patient randomised trial looking at gastric function one and six months postesophagectomy. The food ejection time was reduced in the pyloroplasty group but most other markers including nutritional evaluation, lymphocyte count, rapid turnover protein and body weight fluctuation, were not significantly different. Cheung et al. w13x performed a 72 patient randomised study looking at gastric emptying and late symptoms. They showed significantly quicker gastric emptying at six months, although symptoms did not correlate well with this improvement in transit time. They deemed that two patients in the control group could have benefited from pyloroplasty as the remainder were completely symptom free on follow up. 7. Clinical bottom line Pyloroplasty seems to reduce the incidence of gastric outlet obstruction and speed up gastric emptying. In addition, the incidence of complications from this procedure seems low. However, other significant improvements to outcomes such as mortality, nutrition, anastomotic leakage, gastric symptoms and aspiration, are yet to be established. References w1x Dunning J, Prendergast B, Mackway-Jones K. Towards evidence-based medicine in cardiothoracic surgery: best BETS. Interact CardioVasc Thorac Surg 2003;2:405–409. w2x Urschel JD, Blewett CJ, Young JE, Miller JD, Bennett WF. Pyloric drainage (pyloroplasty) or no drainage in gastric reconstruction after esophagectomy: a meta-analysis of randomized controlled trials. Digest Surg 2002;19:160–164. w3x Fok M, Cheng SW, Wong J. Pyloroplasty versus no drainage in gastric replacement of the esophagus. Am J Surg 1991;162:447–452. w4x Gupta S, Chattopadhyay TK, Gopinath PG, Kapoor VK, Sharma LK. Emptying of the intrathoracic stomach with and without pyloroplasty. Am J Gastroenterol 1989;84:921–923. w5x Mannell A, McKnight A, Esser JD. Role of pyloroplasty in the retrosternal stomach: results of a prospective, randomized, controlled trial. Br J Surg 1990;77:57–59. w6x Chattopadhyay TK, Shad SK, Kumar A. Intragastric bile acid and symptoms in patients with an intrathoracic stomach after oesophagectomy. Br J Surg 1993;80:371–373. w7x Zieren HU, Muller JM, Jacobi CA, Pichlmaier H. Should a pyloroplasty be carried out in stomach transposition after subtotal esophagectomy with esophago-gastric anastomosis at the neck? A prospective randomized study. wGermanx. Chirurg 1995;66:319–325. w8x Kobayashi A, Ide H, Eguchi R, Nakamura T, Hayashi K, Hanyu F. wThe efficacy of pyloroplasty affecting to oral-intake quality of life using reconstruction with gastric tube post esophagectomyx. wJapanesex. Nippon Kyobu Geka Gakkai Zasshi – J Jpn Ass Thor Surg 1996;44:770– 778.
w9x Huang GJ, Zhang DC, Zhang DW. A comparative study of resection of carcinoma of the esophagus with and without pyloroplasty. In DeMeester TR, Skinner DB: Esophageal Disorders, New York, Raven Press 1985;383– 387. w10x Kao CH, Chen CY, Chen CL, Wang SJ, Yeh SH. Gastric emptying of the intrathoracic stomach as oesophageal replacement for oesophageal carcinomas. Nucl Med Commun 1994;15:152–155. w11x Hsu HK, Huang MH, Chien KY, Liu RS, Yeh SH. Functional evaluation of using the stomach as an esophageal substitute. J Surg Assoc ROC 1984;17:186–188. w12x Chattopadhyay TK, Gupta S, Padhy AK, Kapoor VK. Is pyloroplasty necessary following intrathoracic transposition of stomach? Results of a prospective clinical study. Aust NZ J Surg 1991;61:366–369. w13x Cheung HC, Siu KF, Wong J. Is pyloroplasty necessary in esophageal replacement by stomach? A prospective, randomized controlled trial. Surgery 1987;102:19–24.
ICVTS on-line discussion A
Title: Pyloroplasty or no pyloroplasty? Author: Keyvan Moghissi, The Yorkshire Laser Centre, Hull, UK doi:10.1510/icvts.2006.149500A eComment: This question w1x has been asked to my recollection since the 1960s in many meetings, gatherings of specialists groups and societies. However my first personal encounter with comprehensive discussion about it was in one of ‘the Coventry conferences’ organised by Abbey Smith w2x a Consultant Thoracic Surgeon in Warwickshire (UK). Amongst the discussants were Phillip Allison, Norman Barrett, Ronald Belsey, Spencer Payne and Jack Leigh-Collis, as well as R. Giuli (presenting the work of Lortat-Jacob). As a young oesophageal surgeon, though with experience of some 200 oesophagectomies for carcinoma, I listened to the discussion and in particular the remarks made by Professor Collis regarding his own experience of over 400 oesophagectomies for cancer. Lecturing first and discussing at the end of the session with others as participants, he stated: ‘First, with every one of these operations, the mediastinum is reconstituted so that the stomach cannot distend within the chest by the negative intra-pleural pressure. The second thing is that in no case is pyloroplasty done. This, I think, may be important as it does mean that retrograde duodenal reflux into the stomach is avoided. The third point is that every patient after operation is required to sleep against a bed wedge so that he sleeps propped up. The fourth, is that for at least six months after operation, the patient is asked to have extra meals so that he has six small meals a day.’ w2x A few years later I met Professor Collis at a meeting and he enquired about my own views and experience on pyloroplasty. My answer was that in the majority of cases I did carry out pyloroplasty particularly if the stomach was used as a substitute, and in part is left in the chest. He reiterated his original views with the proviso that ‘if the pylorus was scarred or diseased he would employ the procedure.’ I have applied it in my practice and had no cause to regret it. Regarding the article of Khan et al. w1x and the scenario in which one is asked by one’s assistant a question regarding the relevance of pyloroplasty. Unfortunately, there is no straight answer to the question. This evidencebased article has not given an answer to the question posed. It does not consider taking into account important issues such as: • The location of the lesion and the type of oesophagectomy • Substitute used for reconstruction • State of the pylorus whether scarred or diseased It gives pause for thought whether poor evidence equates to good experience. References w1x Khan O, Manners J, Rengarajan A, Dunning J. Does pyloroplasty following esophagectomy improve early clinical outcomes? Interact CardioVasc Thorac Surg 2007;6:247–250. w2x Collis JL. The long term clinical state after resection with gastrooesophagostomy. In: Abbey Smith R, Smith RE, editors. The Coventry Conference; Surgery of the Oesophagus. London: Butterworths, 1972:19–28.
