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Three Part Question

In [patients undergoing esophagectomy] does a [pyloric drainage procedure] improve [early or late clinical outcomes].

Clinical Scenario

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 to a pyloroplasty as he has heard it is associated with improved early post-operative recovery. You do not routinely do this but decide to check the literature after the operation.

Search Strategy

Medline 1966 to November 2006 using the OVID interface.
[exp esophagectomy/ OR esophagectomy.mp or oesophagectomy.mp OR esophagus.mp OR oesophagus.mp OR retrosternal stomach.mp] AND [pyloroplasty.mp OR gastric drainage.mp OR pyloromyotomy.mp]

Search Outcome

A total of 170 papers were identified. One meta-analysis was found that summarised 9 randomized controlled trials. This study together with the best 6 RCTs were selected

Relevant Paper(s)

Author, date and country	Patient group	Study type (level of evidence)	Outcomes	Key results	Study Weaknesses
Urschel et al, 2002, Canada	Meta-analysis of RCTs on the effect of pyloric drainage on patient outcomes. Medline and manual journal search of studies of pyloroplasty or pyloromyotomy. 9 RCTs with 553 patients identified.	Meta-analysis (level 1a)	Mortality drainage versus no drainage	0.92 (95%CI 0.34-2.44) p=0.77	Search strategy for Medline revealed only 11 citations. Used unreliable filters such as randomized controlled trial.pt to narrow the search. 90% pyloroplasties. Informal 'semiquantitative assessment of long term outcomes : late gastric emptying, nutrition and obstructive foregut symptoms better in drainage groups.
			Anastomotic leaks	0.90 (95%CI 0.47-1.76) p=0.77
			Pulmonary morbidity	0.69 (95%CI 0.42-1.14) P=0.15
			Pyloric drainage complications	2.55 (95%CI 0.34-19.0) p=0.36
			Fatal Pulmonary aspiration	0.25 (95%CI 0.04-1.6) p=0.14
			Gastric outlet obstruction	0.18 (95%CI 0.03-0.97) p=0.046
Fok et al, 1991, Hong Kong	200 patients undergoing Lewis Tanner Esophagectomy: Group 1: Pyloroplasty (n=100) Group 2: Control (n=100)	PRCT (Level 1b)	Operative mortality	4 mortalities in control vs. 3 in pyloplasty group	This was a well conducted and large scale study. Although there was a tendency to improved outcomes in patients who underwent pyloplasty, this different was not statistically significant.
			Anastomotic leak	5 leaks in each of the two group
			Pulmonary complications	23 in control group vs 16 in the pyloroplasty group
			Fatal aspiration	2 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
Mannell et al, 1990, South Africa	40 patients undergoing undergoing retrosternal gastric reconstruction of the esophagus: Group 1: Pyloroplasty (n=20) Group 2: Control (n=20)	PRCT (level 2b)	Operative mortality	3 mortalities in control vs 1 in pyloroplasty group	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.
			Fatal aspiration	3 cases in control group vs 0 in the pyloroplasty group
			Early gastric outlet obstruction	9 in the control group vs 1 in the pyloroplasty group
Zieren et al, 1995, Germany	107 patients undergoing subtotal esophagectomy and gastric substitution with cervical esophago-gastric anastomosis Group 1: Pyloroplasty (n=52) Group 2: Control (n=55)	PRCT (level 1b)	Operative mortality	2 mortalities in control vs 4 in pyloroplasty group	Although, well conducted, this study was primarily designed to assess long term 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.
			Anastomotic leak	11 leaks in the control group vs 9 in pyloroplasty group
			Pulmonary complications	8 in control group vs 5 in pyloroplasty group
			Fatal aspiration	0 cases in control group vs 0 in the pyloroplasty group
			Early gastric outlet obstruction	10 in the control group vs 5 in the pyloroplasty group
Kobayashi et al, 1996, Japan	67 patients with esophageal carcinoma underwent subtotal esophagectomy and reconstruction using a gastric tube 34 randomized to pyloroplasty and 33 to a control group. Gastric function evaluated at 1 and 6 months	PRCT (level 2b)	food ejection time of foods	Pyloroplasty 19.6 +/- 31.0 min, Controls 32.9 +/- 37.2 min	Not translated from Japanese Faster gastric emptying shown at 1 month but no nutritional benefits shown at 6 months
			Rapid Turnover protein	No differences
			Prognostic Nutritional count	No differences
Chattopadhyay et al, 1991, India	24 Patients undergoing esophagectomy for with cervical esophago-gastrostomy. Heineke-Mikulicz pyloroplasty. N=12 Control group. N=12	PRCT (level 2b)	Post-operative gastric emptying	No pyloroplasty 370mins+/- 25mins. Pyloroplasty 161mins +/- 23mins P<0.01	Small study Pre-operative gastric emptying mean 38 minutes
			Dumping syndrome	No Pyloroplasty 1 patient Pyloroplasty 2 patients
			Post prandial discomfort	No Pyloroplasty 1 patient Pyloroplasty 0 patients
Cheung et al, 1986, Hong Kong	72 Patients undergoing transthoracic esophagectomy. Randomized to Heineke-Mikulicz pyloroplasty. N=35 Controls. N=37	PRCT (level 2b)	Nasogastric aspiration post-operatively	No Pyloroplasty 266mls+/- 187mls. Pyloroplasty 170mls +/- 142ml p=0.13.
			Gastrograffin swallow 1 week post-op	No Pyloroplasty 1 gross distension, 2 mild symptoms Pyloroplasty no problems
			Gastric Emptying at 6 months ( Half time	No Pyloroplasty 40mins+/- 38mins Pyloroplasty 12mins+/-9.6mins P<0.01

Comment(s)

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 performed a meta-analysis in 2002, finding 9 randomized controlled trials, 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 to 1.14, p=0.15), pulmonary aspiration (odds ratio 0.25 95%CI 0.04 to 1.6, p=0.14), and a significant benefit for gastric outlet obstruction (odds ratio 0.18 95%CI 0.03 to 0.97, p=0.046). 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. The Largest RCT was by Fok et al in 1991, where 200 patients undergoing Lewis-Tanner esophagectomy were randomized to pyloroplasty or control. 13 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 non-significant trends towards benefit. Zieren et al randomized 107 patients to pyloroplasty or control but found no significant differences between the two groups. However the complications rate in this study was low in both groups. Mannell et al 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 performed a small RCT to look a gastric emptying in 24 patients. Emptying was significantly delayed by more than 10 times in both groups post-operatively compared to pre-operatively, but the difference was significantly better in the pyloroplasty group. There were no other differences in either group. Kobayashi et al performed a 67 patient randomized trial looking at gastric function 1 and 6 months post esophagectomy. 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 performed a 72 patient randomized study looking at gastric emptying and late symptoms. They showed significantly quicker gastric emptying at 6 months, although symptoms did not correlate well with this improvement in transit time. They deemed that 2 patients in the control group could have benefited from pyloroplasty as the remainder were completely symptom free on follow up.

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

1. 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. Digestive Surgery 2002;(3):160-4.
2. Fok M, Cheng SW, Wong J. Pyloroplasty versus no drainage in gastric replacement of the esophagus. American Journal of Surgery 1991;162(5):447-52.
3. Gupta S, Chattopadhyay TK, Gopinath PG, Kapoor VK, Sharma LK. Emptying of the intrathoracic stomach with and without pyloroplasty. American Journal of Gastroenterology 1989;84(8):921-3.
4. Mannell A, McKnight A, Esser JD. Role of pyloroplasty in the retrosternal stomach: results of a prospective, randomized, controlled trial. British Journal of Surgery 1990;77(1):57-9.
5. Chattopadhyay TK, Shad SK, Kumar A. Intragastric bile acid and symptoms in patients with an intrathoracic stomach after oesophagectomy. British Journal of Surgery 1993;80(3):371-3.
6. 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. [German]. Chirurg 1995;66(4):319-25.
7. Kobayashi A, Ide H, Eguchi R, Nakamura T, Hayashi K, Hanyu F. [The efficacy of pyloroplasty affecting to oral-intake quality of life using reconstruction with gastric tube post esophagectomy]. [Japanese]. Nippon Kyobu Geka Gakkai Zasshi - Journal of the Japanese Association for Thoracic Surgery 1996;44(6):770-8.
8. 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;383-7.
9. Kao CH, Chen CY, Chen CL, Wang SJ, Yeh SH. Gastric emptying of the intrathoracic stomach as oesophageal replacement for oesophageal carcinomas. Nuclear Medicine Communications 1994;15:152-5.
10. 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;17:186-8.
11. Chattopadhyay TK, Gupta S, Padhy AK, Kapoor VK. Is pyloroplasty necessary following intrathoracic transposition of stomach? Results of a prospective clinical study. Australian & New Zealand Journal of Surgery 1991;61(5):366-9.
12. Cheung HC, Siu KF, Wong J. Is pyloroplasty necessary in esophageal replacement by stomach? A prospective, randomized controlled trial. Surgery 1987;102(1):19-24.